DAILIES AQUACOMFORT PLUS MULTIFOCAL

Additional Manufacturer Narrative

H3, H6: THE COMPLAINT PRODUCT WAS RETURNED FOR EVALUATION AND WAS FOUND TO MEET MANUFACTURING SPECIFICATIONS. THE MANUFACTURING REVIEW DID NOT INDICATE THAT THIS COMPLAINT WAS DUE TO THE MANUFACTURING PROCESS. NO COMPLAINT OR MANUFACTURING TREND WAS IDENTIFIED. THE DEVICE HISTORY RECORD AND STERILIZATION RECORD FOR THIS LOT HAVE BEEN REVIEWED AND FOUND TO BE IN COMPLIANCE. THERE WERE NO NONCONFORMITY OR DEVIATIONS DURING THE MANUFACTURING PROCESS WHICH RELATED TO THE NATURE OF THE COMPLAINT. THE ROOT CAUSE COULD NOT BE DETERMINED. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

Description of Event or Problem

AS INITIALLY REPORTED BY CONSUMER THAT THE LENS TORN IN FOIL PACKAGING, EDGE OF THE CONTACT LENS WAS ROUGH OR IRREGULAR OR NOT CIRCULAR, WHICH CAUSED BURNING AND STINGING SENSATIONS IN LEFT EYE. THEY ALSO STATED THAT CONTACT LENSES BROKE IN THEIR LEFT EYE THREE TIMES. UPON FOLLOW UP THE CONSUMER REMOVED THE BROKEN PIECES THEMSELVES AND SUBSEQUENTLY DEVELOPED AN EYE ULCER AFTER USE OF THE CONTACT LENSES IN THEIR LEFT EYE. THE CONSUMER VISITED AN OPHTHALMOLOGIST AND WAS ADVISED NOT TO WEAR CONTACT LENSES FOR ONE WEEK AND WAS PRESCRIBED AN ANTIBIOTIC AND A STEROID; HOWEVER, THE SPECIFIC AGENTS, DOSAGE REGIMEN (INCLUDING TIMING, FREQUENCY, AND DURATION OF ADMINISTRATION) REMAIN UNKNOWN. ACCORDING TO THE CONSUMER, A FOLLOW-UP CHECK UP WITH OPHTHALMOLOGIST TOOK PLACE, DURING WHICH THE CONSUMER WAS ADVISED THAT NO ISSUES WERE FOUND AND WAS INSTRUCTED TO CONTINUE CONTACT LENS USE. THE CURRENT CONDITION OF CONSUMER EYE WAS RESOLVED AT THE TIME OF THIS REPORT. NO OTHER ADDITIONAL INFORMATION HAD BEEN REQUESTED.

Description of Event or Problem

UPON FOLLOW UP RECEIVED FROM CONSUMER INCLUDING THE MEDICAL RECORDS THEY CONFIRMED THAT CORNEAL ULCER OCCURRED IN RIGHT EYE AND THE LEFT EYE WAS NORMAL. THE CONSUMER STATED THEY EXPERIENCED OF FOREIGN BODY SENSATION, ASSOCIATED WITH PAIN, PHOTOPHOBIA, RED EYE, SCRATCHY, WATERY DISCHARGE AND TEARING IN THE RIGHT EYE AFTER USING THE CONTACT LENS. THE FOREIGN BODY SENSATION HAS BEEN PRESENT FOR THREE DAYS AND WAS TREATED WITH UNSPECIFIED ARTIFICIAL TEARS AND ERYTHROMYCIN WHICH DID NOT RELIEVE THE SYMPTOMS. CONSUMER SOUGHT THE MEDICAL ATTENTION AND WAS DIAGNOSED WITH CENTRAL CORNEAL ULCERATION INFERIOR TO THE VISUAL AXIS IN A SMALL SIZE WITH A DIAMETER OF FOUR TO SIX MILLIMETER. A CORNEAL STAINING WAS DONE USING LESS THAN FIFTY PERCENT OF THE CORNEA AND SEVERITY WAS FOUND TO BE MILD. THE CONSUMER WAS PRESCRIBED WITH 0.5 PERCENT MOXIFLOXACIN DROPS TO BE APPLIED AS ONE DROP FOR EVERY THIRTY MINUTES FOR TWO HOURS AND ONE DROP FOR EVERY TWO HOURS FOR SEVEN DAYS, 0.3-0.1 PERCENT TOBRAMYCIN DEXAMETHASONE EYE DROPS TO BE APPLIED THREE TIMES A DAY FOR SEVEN DAYS. A FOLLOW VISIT WAS SCHEDULED AFTER ONE WEEK. THE CURRENT CONDITION OF CONSUMER EYE WAS RESOLVED AT THE TIME OF THIS REPORT, HENCE WAS ADVISED TO DISCONTINUE THE TREATMENT AND FURTHER FOLLOW UP WAS PLANNED AS REQUIRED.

Additional Manufacturer Narrative

H.3., H.6.: THE COMPLAINT PRODUCT WAS RETURNED FOR EVALUATION AND WAS FOUND TO MEET MANUFACTURING SPECIFICATIONS. A TREND RELATED INVESTIGATION WAS PERFORMED; NO TREND COULD BE IDENTIFIED. THE DEVICE HISTORY RECORD AND STERILIZATION RECORD FOR THIS LOT HAVE BEEN REVIEWED AND FOUND TO BE IN COMPLIANCE. THE MANUFACTURING REVIEW DID NOT INDICATE THAT THIS COMPLAINT WAS DUE TO THE MANUFACTURING PROCESS. NO COMPLAINT OR MANUFACTURING TREND WAS IDENTIFIED. THE ROOT CAUSE COULD NOT BE DETERMINED. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).