PRECISION7

Description of Event or Problem

AS INITIALLY REPORTED BY NON-HEALTH CARE PROFESSIONAL ON BEHALF OF CONSUMER STATING THAT CONSUMER WAS DIAGNOSED WITH CORNEAL ULCER ON UNKNOWN EYE AND WAS PRESCRIBED WITH UNSPECIFIED MEDICATION FOR UNSPECIFIED PERIOD OF TIME DURING MEDICAL CONSULTATION. THE CONSUMER PROCEEDED TO WEAR ONE LENS IN EACH EYE FOR SEVEN DAYS OVERNIGHT STRAIGHT, TOOK LENSES OUT TO CLEAN AND PUT BACK IN FOR ANOTHER WEEK STRAIGHT. CONTINUED THIS SCHEDULED FOR SIX WEEKS UNTIL SHE DEVELOPED A CORNEAL ULCER AND DURING VISIT CONFIRMED THAT SHE WAS WEARING LENSES WHICH THEY WERE NOT PROFESSIONALLY FIT IN BY EYE CARE PROFESSIONAL. THE CURRENT STATUS OF THE CONSUMER EYE IS SYMPTOM CONTINUING AT THE TIME OF THIS REPORT. NO ADDITIONAL INFORMATION CAN BE OBTAINED AS REPORTER DOES NOT WANT TO GET CONTACTED.

Additional Manufacturer Narrative

H.3., H.6.: THE COMPLAINT SAMPLE HAS NOT RETURNED FOR EVALUATION; THE LOT NUMBER IS UNKNOWN. 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. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).