BIOTRUE MULTI-PURPOSE SOLUTION

Additional Manufacturer Narrative

ALTHOUGH REQUESTED, THE PRODUCT WAS NOT AVAILABLE FOR RETURN. A REVIEW OF THE LOT BATCH RECORD AND TESTING OF RETAIN SAMPLES CONCLUDED THAT THE PRODUCT WAS FORMULATED AND MANUFACTURED ACCORDING TO LOCAL AND GLOBAL SPECIFICATIONS. BASED ON ALL AVAILABLE INFORMATION, NO CAUSAL FACTORS CAN BE DETERMINED, AND NO CONCLUSION CAN BE DRAWN.

Description of Event or Problem

A RETAIL LOCATION REPORTED THAT AFTER USING A MULTIPURPOSE SOLUTION A CONSUMER FELT THEIR RIGHT EYE WAS HARD TO OPEN AND EXPERIENCED A FOREIGN BODY/TINGLING SENSATION ACCOMPANIED BY INCREASED TEARING. THE CONSUMER VISITED A HOSPITAL FOR TREATMENT AND UPON EXAMINATION THE PATIENT WAS FOUND TO HAVE BLOCKED MEIBOMIAN GLAND OPENINGS IN BOTH EYES, CONJUNCTIVAL HYPEREMIA, MILD CONJUNCTIVAL HYPEREMIA, PATCHY INFILTRATION OF THE INFERIOR CORNEA, AND REMAINING CORNEAL TRANSPARENCY. THE CONSUMER WAS ALSO DIAGNOSED WITH ACANTHAMOEBA KERATITIS IN THE RIGHT EYE. THE CONSUMER WAS PRESCRIBED CHLORHEXIDINE EYE DROPS, METRONIDAZOLE EYE DROPS, METRONIDAZOLE EYE DROPS, GATIFLOXACIN EYE DROPS AND OFLOXACIN EYE OINTMENT TO THE RIGHT EYE.