PROSHIELD

Additional Manufacturer Narrative

INVESTIGATION INCLUDING ROOT CAUSE DETERMINATION IS IN PROGRESS.

Description of Event or Problem

A SURGEON REPORTS DIFFICULTY WITH THE COLLAGEN CORNEAL SHIELD. DURING SURGERY, THE SHIELD WAS SOAKED IN A TOPICAL ANTIBIOTIC WITH A STEROID, AND THEN PLACED ON THE CORNEA. (THE PATIENT WAS BEING TREATED WITH A HYPER OSMOTIC TREATMENT.) THE PATIENT DEVELOPED CORNEAL EDEMA WHICH HAS LASTED FOR ONE MONTH. THE SURGEON HAD TO PHYSICALLY REMOVE THE CORNEAL SHIELD FROM THE PATIENT'S EYE. THE PATIENT IS EXPERIENCING POOR VISION AND A FIXED PUPIL. THE PATIENT STATED SHE FELT LIKE THERE WAS A FOREIGN BODY IN HER EYE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.