AIR OPTIX PLUS HYDRAGLYDE

Description of Event or Problem

AS INITIALLY REPORTED BY A HEALTHCARE PROFESSIONAL ON BEHALF OF CONSUMER STATED THAT CONTACTS ARE SOMEHOW DEFECTIVE, WHEN WEARING A NEW PAIR OF CONTACT LENSES, BOTH EYES IMMEDIATELY EXPERIENCED A SCRATCHY SENSATION, WHICH LED TO ULCERS. THERE IS NO AVAILABLE INFORMATION REGARDING ANY MEDICAL INTERVENTION OR TREATMENT RECEIVED. THE CURRENT STATUS OF THE CONSUMER¿S EYES IS UNKNOWN AT THE TIME OF THIS REPORT. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT HAS NOT YET BEEN RECEIVED.

Additional Manufacturer Narrative

H.3., H.6.: THE COMPLAINT SAMPLE HAS NOT RETURNED FOR EVALUATION. INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. THIS IS THE FIRST OF TWO REPORTS FOR THE SAME PATIENT INVOLVING TWO DIFFERENT LOT NUMBERS OF THE SAME PRODUCT. IT IS UNKNOWN WHICH CONTRIBUTED TO THE EVENT. REFER TO THE SECOND REPORT FILED UNDER THE FILE ID: (B)(4). THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4). H.10 REFLECTS ALL RELATED REPORT NUMBERS ASSOCIATED WITH THIS PRODUCT EVENT THAT HAVE BEEN SUBMITTED AT THIS TIME.