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CooperVision ICD 16.5Sph Instructions For Use Manual

Rgp contact lenses

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Manufacturer and registered owner: CooperVision Israel Ltd, Bar-Lev, 2015600, IL
Telephone number: 04-9955600
General Inquiries & Technical Support:
CooperVision CL Kft.
Gorcsev Iván street 7. Building C. 2360 Gyál Hungary
All information in this manual is believed to be correct. CooperVision shall not be liable for
errors contained herein with the performance or use of this manual.
1. Introduction
This operator's manual provides the information necessary to safely wear of RGP Contact
Lenses for annual replacement schedule.
DOC026 Revision: 7
Revised Date: August 7 ,2022
RGP Contact Lenses
Instruction For Use
contact@coopervision.co.il
Page 1 of 13

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Summary of Contents for CooperVision ICD 16.5Sph

  • Page 1 CooperVision CL Kft. Gorcsev Iván street 7. Building C. 2360 Gyál Hungary All information in this manual is believed to be correct. CooperVision shall not be liable for errors contained herein with the performance or use of this manual. 1. Introduction This operator’s manual provides the information necessary to safely wear of RGP Contact...
  • Page 2 (cornea) of the eye. This flow of oxygen contributes to the health and comfort of the eye. Product name, Indications and Trade name - Indications RGP Lenses - Group Trade Name Name Rigid-gas- Trade Name Article no. permeable ICD 16.5Sph 6010 corrective contact ICD 14.5Mini 6009 lens, ICD16.5 Toric 6011 Daily-wear ICDFF14.8 6012 ICDFF14.8DDT...
  • Page 3 NaturalFT 6019 SoflexNDFT 6049 SPEHARD-FT 6051 Trade Name Article no. 6031 Back Toric OPTLITE 6032 OPT PERIPHERY 6033 Rigid-gas- Trade Name Article no. permeable OVERNIGHT 6035 Ortho-K Orthokeratology OVERNIGHTSt 6036 contact lens Orthotool 6034 Overnight wear Trade Name Article no. Paragon CRT100 6002 Paragon CRTDA...
  • Page 4 There are certain health conditions in which RGP contact lenses should not be worn. You should alert your eye care practitioner to any of the conditions listed below. Only your eye care practitioner can determine if contact lens wear is right for you. •...
  • Page 5 • Due to the small number of patients enrolled in clinical investigation of lenses, all refractive powers, design configurations, or lens parameters available in the lens material are not evaluated in signification numbers. Consequently, when selecting an appropriate lens design and parameters, the eyecare practitioner should consider all characteristics of the lens that can affect lens performance and ocular health, including oxygen permeability, wettability, central and peripheral thickness, and optic zone diameter.
  • Page 6 • Inspect lenses before inserting them in the eye. The patient should be instructed how to inspect their lenses with examples of intact, chipped, and cracked lenses. • If the lens sticks (stop moving) on the eye, follow the recommended directions on CARE FOR A STICKING LENS.
  • Page 7 You should be aware of the following problems that may occur: • Eye pain • Eye's sting, burn or itch (irritation) • Comfort is less than when is your lens was first placed on your eyes. • Abnormal feeling of something in your eye (foreign body, scratched area) •...
  • Page 8 2. Place the right index finger at the outer corner of the eye. 3. Place the left hand cupped below the eye. 4. Open the eyes wide as if to stare. 5. Continue to keep the eyes open and pull the lids sideways away from nose. 6.
  • Page 9 sensation. In the event of foreign body sensation, the patient should remove the lens, clean and rewet it and replace the lens. If the sensation continues, the lens should not be worn. The patient should report for follow-up evaluation the morning after the first overnight wear.
  • Page 10 or mix lens care system unless indicated on solution labeling or as recommended by your eyecare practitioner. • Always carefully inspect lenses for cracks, or scratches, before inserting them into the eye. Discomfort and injury may result if cracked or scratched lenses are placed in the eye.
  • Page 11 • Eyecare practitioners may recommend a lubricating / rewetting solution which can be used to wet (lubricate) lenses while they are being worn to make them more comfortable. 15. Lens Case Cleaning and Maintenance Contact lens cases can be a source of bacteria growth. Lens cases should be emptied, cleaned, rinsed with rinsing solution, and allowed to air dry.
  • Page 12 All serious adverse experiences and adverse reactions observed in wearing the patient wearing the RGP Contact Lens for daily wear lens (or as directed by the ECP) should be reported to CooperVision (see details below) and the competent authority of the Member State in which the user and/or patient is established.
  • Page 13 Fax: 00972-4-9911025 DOC026 Revision: 7 Revised Date: August 7 ,2022 Page 13 of 13...