BIOTRUE MULTI-PURPOSE SOLUTION

Additional Manufacturer Narrative

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 IN PROGRESS. BASED ON ALL INFORMATION, NO CAUSAL FACTORS CAN BE DETERMINED AND NO CONCLUSION CAN BE DRAWN.

Description of Event or Problem

A CONSUMER REPORTED TO THEIR RETAIL STORE THAT AFTER WEARING CONTACT LENSES AND USING A LENS CARE SOLUTION THEY EXPERIENCED BLURRED VISION, DRYNESS, AND STINGING IN THEIR RIGHT EYE. THEY VISITED A HOSPITAL FOR TREATMENT WHERE THEY WERE ADMITTED FOR 6 DAYS AND WERE DIAGNOSED WITH KERATITIS IN RIGHT EYE. THE EXAMINATION DETERMINED THE RIGHT EYE CONJUNCTIVA WAS MIXED WITH CONGESTION (++) AND A SMALL AMOUNT OF PURULENT SECRETIONS ARE SEEN IN THE CONJUNCTIVAL SAC. THERE WAS AN EXTENSIVE PUNCTATE DEFECT OF THE CORNEAL EPITHELIUM. THE CORNEA WAS MILDLY FOGGY. THE ANTERIOR CHAMBER IS DEEP 3CT, THE AQUEOUS HUMOR WAS CLEAR, AND THE PUPIL IS ABOUT 3MM IN SIZE. THE LIGHT REFLECTION WAS SENSITIVE. THE POSTERIOR STRUCTURE WAS NOT CLEAR. DURING THEIR HOSPITALIZATION, THEY WERE GIVEN INTRAVENOUS CEFUROXIME AND DEXAMETHASONE SODIUM PHOSPHATE FOR INFLAMMATION. LEVOFLOXACIN EYE DROPS FOR INFECTION. TOBRAMYCIN DEXAMETHASONE EYE DROPS FOR INFLAMMATION. BOTH EAR AND EYE ACUPUNCTURE. ALSO, A LOCAL ADMINISTRATION OF RECOMBINANT BOVINE BASIC FIBROBLAST GROWTH FACTOR EYE GEL TO PROMOTE CORNEAL REPAIR. THE CONSUMER WAS DISCHARGED AFTER 6 DAYS IN THE HOSPITAL AND IS CURRENTLY RECOVERING.