Soft Hydrophilic Contact Lens Instructions   

Warning: The purpose of this manual is to guide the wearer how to correctly wear and nurse the soft hydrophilic contact lens (hereafter referred to as lens or contact lens or soft lens). Please read this manual carefully before the wear and wear contact lens under the guidance of eye doctor or professional optometrist.

【Registration Certificate No./ Product Technology Requirement No.】SFDA certified No. 20173223026

【Product Name】soft hydrophilic contact lens

【Commodity Name】without 

【English Name】without

【Model Number】Realcon 38

【Specificationlight blue

【Approval Date of the Instructions】January 16, 2017

【Revision Date of the Instructions】March 13, 2017

Version No.3

【Warning】

1. This product directly touches the cornea, if not follow the application method or relevant precautions, it may cause various eye disease, even blindness. Before the use, please make sure to read carefully this manual, follow the doctor’s orders, wear the lens according to correct method of application.

2. Recommend to decide to wear this product after the inspection and evaluation of the ophthalmologist. While wearing this product, it needs the fitting of ophthalmology and optometry professionals.

3. If wear this product, it could make the damage risk of cornea and conjunctiva increase, even cause the eye diseases such as keratitis, keratohelcosis, etc. So, while there are the abnormal phenomena such as eyes secretions increase, reddening eyes, sore eyes, photophobia, abnormal sensation, lacrimation, blurred vision,etc.,one should immediately stop wearing and go to the hospital to receive the ophthalmologist’s inspection as soon as possible. Delay treatment may cause the permanent visual impairment.

4. Even if correctly use this product, owing to the existence of individual difference, it may produce the change such as the decrease of corneal endothelial cell, formation of corneal neovascularization, etc.

5. The wearer must follow the instructions of ophthalmology professionals and product usage manual as well as use the soft contact lens care product that has already gained the medical device registration certificate. It forbids to use other substitutes such as cleaning solution, soap, etc. to clean the lens, and forbids to use other substitutes such as alcohol to sterilize the lens.

6. Strictly wear the contact lens according to “wearing timetable”. The daily lens cannot be used while sleeping. Clinical experiment has proved that if wear the contact lens while sleeping, the risk of serious adverse events will increase significantly.

7.The first time contact lens wearer should go to the hospital for a periodic review after wearing contact lens for the first day, the first week, the first month and the third month. Afterwards, even if there is no discomfort, it recommends to go to the hospital to examine the eyes periodically(or follow the doctor’s orders).

8. Sterilized, before unsealing, please confirm that the package is intact. If the package is damaged, please don’t use this product.

9. This product belongs to medical device, before purchase, please confirm that the product label is printed with medical device registration number.

10. This is plano decorative lens and doesn’t possess the function of correcting refractive error, but has the same risk with the correction function lens. So, it should be used with caution.

11. This product is for repetitive use.  

【Special ExplanationThis product is personally used by the consumer, hope the consumer consult the seller before the purchase and learn to use the wearing and nursing method.  

【Application Range】This product is for daily wear contact lens, which is used for the ones without contraindication in order to correct myopia.    

【Taboo

1. If one is diagnosed with the multiple eye diseases, such as acute or chronic eyes inflammation, glaucoma, abnormal corneal perception, corneal epithelial defects, decrease of corneal endothelial cells, xerophthalmia, etc., cannot wear contact lens after the ophthalmologist’s estimate.

2. If one is diagnosed with the systemic disease that is probably influential to the eyes, cannot wear contact lens after the ophthalmologist’s estimate.

3. The one who has the contact lens allergic history or contact lens care products allergic history.

4. The living environment or working condition is not suitable to wear soft lens, for example, dust, medicine, aerosol(such as hair spray and volatile chemical), dirt that are permeated in the air.

5. The one who cannot wear the soft lens according to the requests.

6. The one who cannot inspect the eyes regularly.

7. The one whose personal hygiene doesn’t possess the sanitary condition that is necessary to the contact lens wearer.

【Notes】

1. Wearing the contact lens every day to develop a habit, always take and wear the same lens in case of confusion, recommend to first wear the right lens, then left lens. After removing the lens, put it in the corresponding indicative contact lens case. If confused and cannot distinguish the right from the left, please seek the ophthalmologist or optometry professional’s help. If wear the reverse side of soft contact lens, the eyes will have obvious discomfort and pricking sensation. Usually use the following methods to differentiate the positive and negative side of contact lens(outward-looking approach). Put the contact lens on the finger, if the inside of edge looks like the bowl(as the following photo 1), it is the positive side; if it unfolds like the saucer(as the following photo 2), it is the negative side.

circle contact lens 

2. If wear the soft lens for the first time, one may have slight lens moving feeling or discomfort in the initial one or two weeks. Usually it could be disappeared spontaneously. If the abnormal sensation is relatively evident, or there are the irritant symptoms such as blurred vision, reddening eyes, photophobia,lacrimation, etc.,one should immediately remove the lens and look for the cause. The reasons that may cause the above problems are that ① the lens is not placed in the middle of cornea; ② the lens is polluted and damaged; ③ right and left lens being out-of-order; ④ other reasons. If the symptoms continue, one should promptly go to the hospital to receive the ophthalmologist’s inspection.

3. This product forbids to heat or freeze.

4. While wearing the contact lens, if needs to use the medicine especially eye drops, one must consult a doctor.

5. If one is in pregnancy, lactation period or recently planning to become pregnant, one must consult a doctor.

6. If one has the history of wearing cornea orthokeratology, one please consult the doctor before wearing the soft contact lens.

7. While doing water or underwater diving activities such as bathing, swimming and surfing with soft lens, the lens may fall off. Meanwhile, the eyes infection risk may increase. So, donnot recommend to wear the lens.

8. Please donnot wear the soft lens during the illness, such as cold, fever, over fatigue, etc.

9. Please make up after wearing the lens, first remove the lens and then remove the makeup.

10. If use spray such as hair spray, perfume,etc. while wearing contact lens, please be careful to use and close your eyes until the smoke is disappeared, escaping from entering the eyes.

11. Please drive the motor vehicle after completely adapting to wearing contact lens.

12. One should not share wearing the contact lens with other people.

13. Please put the contact lens far from the place that child can touch.

14. If the contact lens is removed from the eyes, exposed in the air and become dry, one forbids to reuse the lens.

15. While wearing the contact lens, please forbid to engage in furious collision and body antagonism sports.

【Wear Timetable】

This lens is for daily lens. While wearing the lens for the first time, the eyes may have different degrees of abnormal sensation. Please refer to the following Table 1 timetable to wear the lens and can make the eyes gradually adapt to the soft lens.

Table 1 Wear Timetable

Start to wear lens days

1

2

3

4

5

6

Wear time (hour)

4

6

8

10

10

10

1. Comply with the wearing time. The first time wear or re-wear after stopping wearing, from wearing 4 hours every day, add 2 hours every day. It forbids to wear the lens while sleeping.

2. The longest wearing time shouldn’t pass the longest time in Table 1. The wearing time varies with each individual, please don’t wear the lens overtime.

3. If interruptedly wear the lens owing to stopping wearing halfway, then it should readjust according to the first time wearing time.

4. The suggested change period of the lens, please refer to the Table 2. While the actual service life, please follow the doctor’s orders.

 

【Performance Structure and Constituent】

The contact lens design description: This product’s manufacturing technique is the mixing technique of turnery and mold pressing. The internal surface of contact lens adopts molding pressing method, while the external surface of contact lens adopts the turnery method. The printing method is internal coating printing and dyeing technique. The contact lens is non-ionic.

Please refer to the following Table 2 in regard to the relevant information of contact lens.

Table 2 Lens Relevant Information

Content Name

content or unit

Lens Material

HEMA, MMA, NVP, TEGDMA, AIBN and colorant

Preservation Solution Type

sodium chloride, boracic acid, borax, purified water

Power Range (D)

+6.00 D to -12.00 D, +6.00 D -10.00 D, step 0.25 D ; -10.00 above to -12.00, step 0.50 D

Refractive Index

1.438

Water Content

38%

Visible Spectrum Average Transmittance

95%

 Optical Transmissivity

Under the condition of simulated use, separately measure the light transmissivity under the standard illuminant D65 and A, the result is all 89%.

Uvioresistant

without

Color

Light blue

Base curve (mm)

from 8.30 to 8.80mm, step 0.1mm

Diameter (mm)

from 13.50 to 14.50 mm, step 0.1mm

Center Thickness

Refer to table 2 continue

DK

9.38×circle contact lens

DK/t

8.63×circle contact lens ; (-3.00D)

Wear Method

daily wear type, the longest wearing time each day should be less than 10 hours

Suggested Change Period

The longest change period is within one year.

Sterilization Method

Steam moist heat sterilization

Production Date

Refer to the label

Expiry Date

5 years

Iinitial Packing Material

Vial packing: vial+rubber plug+cap

Storage Condition

The contact lens should be stored in dry, cool and non-corrosive room. The indoor temperature should be controlled at the temperature above 4 .  

 

 

Table 2 Continue  Power and Center Thickness Table

Power Range(D)

Center Thickness (mm)

Power Range(D)

Center Thickness (mm)

+4.50 ~ +6.00

0.16

-0.50 ~ -1.75

0.11

+2.75 ~ +4.00

0.15

-2.00 ~ -3.75

0.10

+1.25 ~ +2.50

0.14

-4.00 ~ -4.75

0.09

+0.75 ~ +1.00

0.13

-5.00 ~ -5.75

0.08

+0.25 ~ +0.50

0.13

-6.00 ~ -6.50

0.07

0.00 ~ -0.25

0.12

-7.00 ~ -12.00

0.06

【Operating Principle or Mechanism of Action】

The soft hydrophilic contact lens is mainly used for correcting the medical device of various eyes refractive error. On the above these refractive errors, light ray cannot properly focus on the retina, resulting in blurred vision. While the lens is placed on the cornea, as the optical element in front of the eyes, with combination of optical fuction, the light ray will fitly focus on the retina, bringing a clear vision.

【Package Internals】

Vial package, one piece. Small package is vial packing, medium package is foam, external package is corrugated case.

Blister package, one piece. Small package is polypropylene box, medium package is foam, external package is corrugated case.  

【Care Solution Precautions for Use】

This product can use the currently allowed to be listed soft lens that apply to care solution and related matching products. Please refer to the related product’s manual or consult relevant ophthalmologist or ophthalmology and optometry professionals in details.

And pay attention to the following contents:

1. Please use strictly according to the different types of care solution manual, shouldn't make the order of use upside down, and shouldn’t mix or replace different care solution.

2. The care solution must use within the shelf-life and opening bottle expiry date, and it must abandon after expiry.

3. It forbids the dirt from the outside to touch the bottleneck such as finger, lens or lens case, etc. After opening the bottle cap, internal opening of the bottle cap should put upward.

4. Store under the normal temperature, shielded from light and dry conditions

5. If the care solution has the opacification during normal use, or eyes discomfort in the process of use, such as eyes red, shed tears, etc., then it should stop using immediately as well as consult the doctor.

6. It should abandon and forbid the repetitive use of the care solution that has already touched the contact lens.

【Lens Wear and Remove Method】

1. Note:

① Donnot knead and rub the contact lens with overexertion, in case of damaging the lens

② It should clean, de-protein, wash, sterilize, store and wear the lens strictly according to prescribed procedure and requirement, and it cannot replace each other among various steps.

③ Before wearing the lens, it must use specialized care solution possessed with disinfection function to soak. The soak timetable please refer to the regulations of the care solution manual in details.

④ If the lens is kept and not worn over one week, re-cleansing and re-sterilization the lens is necessary before wearing the lens.

2. Preparation Stage

① One should receive the professional’s specific guidance about the wearing method.

② Every time before touching the lens, one should wash the hands fully with mild soap and running water.

③ Keep the fingernail short, neat and trim. Forbid to make the fingernail to touch the lens during the process of wearing, taking out and nursing the soft lens.

④ Nurse or take the lens on the clean and smooth desktop, in case of falling off on the ground or getting lost.

⑤ Wearing the contact lens every day to develop a habit, always take and wear the same lens in case of confusion, recommend to first wear the right lens, then left lens.

⑥ Develp a habit, every time before wearing the lens, one needs to check that whether the lens appearance meets the requirement, confirm it is humid and clean. One must not use if the contact lens has the appearance abnormal conditions such as spot, residual impurities, bubble, crack, damage, etc., it should not be used.

3. Lens Wear Procedure

① Before wearing the contact lens, keep the hands clean and dry, and put negative camber of the lens upward and bear it upon the finger tip.

② Confirm the positive and negative side

③ Face down and look down the mirror on the desktop      

④ Use forefinger or middle finger to press on the upper eyelid edge of the wearing eyes, open the eyelid fully upward, and press on the arcus superciliaris as fixation. With the other hands to press on the lower eyelid edge of the wearing eyes, open the eyelid fully downward.

⑤ Gently put the lens in the center of the exposed cornea(black eyeball) of the wearing eyes

⑥ Gently wink several times and use the tissue to wipe away overflowed liquid. According to the above method, in the sequence of first right then left, wear the contact lens. During the process of wearing lens, if the lens is crowded out the eyes or fell off on the desktop, it must reuse the care solution to cleanse and disinfect first, then re-wear the lens.

4. Lens Remove Procedure:

① According to the requirements in the 2rd Preparation Stage, be ready-to-wear;

② The same as the method while wearing the contact lens, open fully the eyelid of the wearing lens eyes;

③ Use the finger pulp of thumb and index finger to lightly pinch the lower part of the lens and gently remove the lens

【Lens Care and Store】

1. Inject in advance 2/3 capacity care solution that is possessed with disinfectant and stored function in the lens case.

2. Place the removed lens in the heart of the palm, drip 2~3 drops of the recommended care solution with disinfectant and stored function.

3. Use the forefinger to gently rub 20 times the obverse and the reverse side of the lens.

4. Use the recommended care solution with washing function to fully wash the lens. During the washing process, it should be refrained from the contact between care solution bottleneck and soft lens.

5. Put respectively the washed lens into each lens case. In regards to the soak time of the care solution with disinfectant function, please refer to the regulations of the care products manual.

6. While the lens is not used for a long time, it strictly needs to cleanse, wash, disinfect and store in the care solution with the saved function. Every 7 days should change the stock solution. Before the re-wear, it needs fully cleanse, wash, soak and disinfect the lens. In regards to the soak time, please refer to the regulations of the care products manual.

7. Cleaning, deproteinization, washing and disinfection, each step should not be replaced with each other.

8. Deproteinization enzyme solutions can help to remove the protein deposit on the lens. The multi-functional care solution with the deproteinization function cannot replace the deproteinization enzyme solutions. The use of deproteinization enzyme solutions cannot replace the conventional cleansing and disinfection. On average, it recommends to use the deproteinization enzyme solutions to dispose the lens every 7 days. One should carefully carry out the operation according to the manual of deproteinization enzyme solutions .

【Lens Case Cleaning】

   1. Lens case is the important source of microbial pollution. In order to prevent the eyes infection, the lens case needs to be cleansed, washed and air-dried after everyday use.

   2. Every week use clean special brush and purified water to wash and clean, scald and air drying of the inside and outside of the lens case, and keep the sanitation and hygiene of the lens case.

   3. Please regularly change the lens case according to the time recommended by the lens case manufacturer or ophthalmology and optometry professionals.

【Emergency Response

1. If the lens is adhered by(stop moving) or unable to remove, one should directly drip several drops of recommended lubricating liquid into the eyes. Wait until the lens is able to move freely on the surface of the eyes, then the lens should be taken out. If still the lens could not be taken out, one should immediately go to the hospital for treatment.

2. If any types of chemical substances(such as household product, all kinds of solutions, laboratory chemicals, etc.) are splashed into the eyes, one should use lots of running water to wash the eyes, take off the lens, and immediately go to the hospital for treatment.

3. If the dust and particles from the external surroundings enter the eyes, it may cause the eyes discomfort. At this time, one must not rub the eyes, can drop lubricating liquid, and after removing the lens, one should completely clean the lens. If the uncomfortable feeling continutes, one should immediately go to the hospital for treatment.

4. If the lens translocates during the process of wearing lens, one can seek the moved lens by looking into the mirror. Firstly look at the reverse direction of the lens location, use the fingers to fix the eyelid besides the lens and indirectly fix the lesn, but donnot press on the moved lens. Please slowly look at the lens direction. In this way, the moved lens can return to the center of the cornea. If the above method cannot make the lens back to its original place, one can take off the lens and re-wear the lens.

【Storage Condition and Expiry Date】

The circle contact lens storage condition and the expiry day from the date of manufacture please refer to table 2. Batch number, date and expiry date please refer to the labels.

Please wear the contact lens before the date that is indicated on the sterile package(or external case).

【Graph and Symbol Explanation】

Symbol: the following symbol could appear on the volume label or external package

Symbol

Explanation

Symbol

Explanation

circle contact lens 

Sterility and Steam Moist Heat Sterilization

BC

Base Curve

circle contact lens 

Read the instruction for use in details

F’v

Power or Back Vertex Power

circle contact lens 

Lot Number

circle contact lens

Diameter

circle contact lens 

Expiry Date

circle contact lens 

Qualification

 

circle contact lens 

One should use the contact lens under the prescription and instructions of medical doctor.

 

 circle contact lens 

Production Date

 

【Registrant / Manufacturer】

Company Name: Jilin Realcon Contact Lens Co.,Ltd.

Residence: Room 601, Building E, 86 Shenzhen Street, Gaoxin District, Jilin, China

Production Address: Room 601 and 400, Building E, 86 Shenzhen Street, Gaoxin District, Jilin, China;

                 A-5-9, Industrial 3rd District, Gaoxin District, Jilin, China

Postal Code: 132012

Phone No.: 0432-65042829

Fax No.: 0432-64686396

 

【After-sales Service Agency】

Company Name:Jilin Realcon Contact Lens Co.,Ltd.

Residence: Room 601, Building E, 86 Shenzhen Street, Gaoxin District, Jilin, China

Production Address: Room 601 and 400, Building E, 86 Shenzhen Street, Gaoxin District, Jilin, China

                 A-5-9, Industrial 3rd District, Gaoxin District, Jilin, China

Production / Business License No. : Jilin FDA Production Permission No.20150001

Postal Code: 132012

Service Call: 0432-65042829

Fax Number: 0432-64686396

Website: www.realconlens.com