THE COMPLAINT SAMPLE WAS NOT RETURNED FOR EVALUATION. CONSUMER REVEALED THAT THE HYDROGEN PEROXIDE SYSTEM IN USE WAS EXPIRED; ALSO, THE CONSUMER WAS UNWILLING TO PROVIDE LOT INFORMATION ASSOCIATED WITH THE CONDITIONING SOLUTION. ADDITIONAL MEDICAL INFORMATION HAS BEEN REQUESTED BUT HAS NOT BEEN RECEIVED. IT SHOULD BE NOTED THAT EYES WITH KERATOCONUS MAY DEVELOP SEVERE CORNEAL SCARRING OR BECOME UNABLE TO TOLERATE A CONTACT LENS AS A NORMAL COURSE OF THE CONDITION (NATIONAL EYE INSTITUTE). BASED ON AVAILABLE INFORMATION, NO CAUSAL FACTORS CAN BE DETERMINED AND NO CONCLUSION CAN BE DRAWN.
D
Patient 1
A CONSUMER REPORTED BEING DIAGNOSED WITH A CORNEAL ULCER IN HER RIGHT EYE. THE CONSUMER WEARS A SCLERAL LENS TO CORRECT KERATOCONUS AND REPORTED THAT SHE SOAKS THE LENS DAILY IN THE CONDITIONING SOLUTION AND THAT SHE CLEANS AND DISINFECTS WITH THE HYDROGEN PEROXIDE SYSTEM WEEKLY. A REPRESENTATIVE AT THE PRACTICE WHERE THE CONSUMER WAS SEEN REPORTED THAT IN ADDITION TO KERATOCONUS, THE PATIENT ALSO HAS A HISTORY OF CORNEAL INFILTRATES, GLAUCOMA, AND DRY EYES. UPON HER INITIAL VISIT RELEVANT TO THIS EVENT, THE OFFICE NOTED THAT THE PATIENT PRESENTED WITH A RED EYE AND WITH COMPLAINTS OF A BURNING SENSATION. THE EYE DOCTOR DIAGNOSED A NON-INFECTIOUS ULCER IN THE CENTRAL 6MM OF THE CORNEA OF THE RIGHT EYE AND PRESCRIBED AN ANTIBIOTIC (OFLOXACIN) AND CORTICOSTEROID (PREDNISOLONE ACETATE). THE DOCTOR NOTED THAT THE LENSES WERE HEAVILY COATED WITH PROTEIN AND RECOMMENDED A DEEP CLEANING. ON A FOLLOW-UP VISIT TWO DAYS LATER, THE PATIENT RETURNED WITH LESSENING SYMPTOMS. PUNCTATE KERATITIS IN THE RIGHT EYE WAS NOTED. FIVE DAYS LATER, THE PATIENT FOLLOWED-UP ONCE AGAIN AND THE OFFICE REPRESENTATIVE INDICATED THAT THE PATIENT?S CONDITION HAD RESOLVED. PATIENT IS RECOVERED. OFFICE REPRESENTATIVE STATED THAT THERE WAS NO PERMANENT DECREASE IN VISUAL ACUITY. NO FURTHER FOLLOW-UPS RELEVANT TO THIS EVENT HAVE BEEN SCHEDULED.