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MENICON Z RIGID GAS PERMEABLE (RGP) CONTACT LENS

Received Apr 27, 2004 · Event occurred Aug 4, 2003

Report 3003515967-2004-00003 · MDR key 559601

Device

Generic name

Rgp Contact Lens

Manufacturer

Menicon Co. Ltd.

Model number

*

Catalog number

*

Lot number

*

Product problems

  • Other (for use when an appropriate device code cannot be identified)

Patient

UNKNOWN

  • Corneal Abrasion
  • Discomfort
  • Numbness

Narrative

Description of Event or Problem

THE PT PARTICIPATING IN THE POST APPROVAL STUDY OF THE MENICON Z RGP CONTACT LENS FOR UP TO 30 DAYS/29 NIGHTS OF EXTENDED WEAR WAS SEEN BY A DR (O.D.) IN 2003 WITH A SMALL CENTRAL ABRASION ON THEIR RIGHT CORNEA FOR WHICH THE PT HAD NO SENSATION. THE DR HAD THE PT DISCONTINUE WEAR OF THE MENICON Z LENSES FOR 3 DAYS AND, THEN, RE-START THEIR EXTENDED WEAR SCHEDULE. AFTER 12 WEEKS, THE PT RETURNED TO THE DR SAYING THAT THEIR RIGHT EYE WAS UNCOMFORTABLE AND THE PT HAD SOME CORNEAL EPITHELIAL DEFECTS WHICH OVER THE COURSE OF THE NEXT 3 WEEKS DID NOT IMPROVE. A NEW PAIR OF MENICON Z LENSES WERE DISPENSED IN 2004 BUT THIS EPITHELIAL DEFECT ON THE PT'S RIGHT CORNEA DID NOT IMPROVE. IN 2003, THE DR DISCONTINUED THE PT FROM THE POST APPROVAL STUDY DUE TO THE ABOVE EPITHELIAL DEFECT. THE PT GOT BACK TO DAILY WEAR SCHEDULE WITH OTHER MATERIAL RGP CONTACT LENS.