ULTRA FOR PRESBYOPIA CONTACTLENS

Additional Manufacturer Narrative

PRODUCT HAS BEEN REQUEST BUT HAS NOT BEEN RETURNED TO MANUFACTURING. A REVIEW OF THE MANUFACTURING RECORDS CONCLUDES THAT THE PRODUCT WAS MANUFACTURED, PACKAGED AND RELEASED ACCORDING TO GLOBAL AND PLANT PRODUCT SPECIFICATIONS. BASED ON ALL AVAILABLE INFORMATION, NO CAUSAL FACTORS CAN BE DETERMINED AND NO CONCLUSION CAN BE DRAWN.

Additional Manufacturer Narrative

INVESTIGATION IS ONGOING. BASED ON ALL AVAILABLE INFORMATION, NO CAUSAL FACTORS CAN BE DETERMINED AND NO CONCLUSION CAN BE DRAWN.

Description of Event or Problem

AN OPTICIAN REPORTED THAT A CONSUMER DEVELOPED AN ABSCESS IN THEIR RIGHT EYE. SYMPTOMS INCLUDED PAIN AND REDNESS. THE CONSUMER WAS EVALUATED AND MONITORED BY AN OPHTHALMOLOGIST WHO PRESCRIBED INTENSIVE TOPICAL TREATMENT CONSISTING OF INDOCOLLYRE (INDOMETACIN), TOBREX (TOBRAMYCIN), AND DESOMEDINE (HEXAMIDINE), INITIALLY APPLIED HOURLY. AFTER 15 DAYS OF TREATMENT, THE DOSAGE WAS REDUCED TO 8 TIMES A DAY, THEN 6 TIMES A DAY, AND FINALLY TO TWO ANTIBIOTICS, 4 TIMES A DAY. THE OPHTHALMOLOGIST ATTRIBUTED THE ABSCESS TO CONTACT LENS USE. THE CONSUMER WAS ON TREATMENT FOR APPROXIMATELY TWO MONTHS. THERE WAS COMPLETE RESOLUTION OF THE ABSCESS AND NO SUBSEQUENT PERMANENT DAMAGE TO THE EYE. THE CONSUMER WAS PROVIDED WITH NEW BOXES OF CONTACT LENSES, AND RESUMED LENS WEAR WITHOUT FURTHER ISSUES.