BOSTON ORTHO-K (OPRIFOCON A) SHAPING LENS

Description of Event or Problem

PATIENT PRESENTED TO A LOCAL CLINIC WITH SYMPTOMS OF OCULAR PAIN, LIGHT SENSITIVITY, AND DECREASED VISION IN BOTH EYES, AFTER WEARING ORTHOKERATOLOGY CONTACT LENSES OVER NIGHT FOR FIVE DAYS. THE PATIENT WAS DIAGNOSED AS HAVING BILATERAL INFECTIOUS CORNEAL ULCERS, WITH EITHER VIRAL OR FUNGAL KERATITIS. THE PATIENT WAS TREATED WITH ANTIVIRAL AND ANTIFUNGAL MEDICATIONS. APPROXIMATELY ONE MONTH LATER, THE PATIENT PRESENTED TO A HOSPITAL DOCTOR, AS SYMPTOMS CONTINUED AFTER ONE MONTH OF TREATMENT. THE PATIENT WAS DIAGNOSED AS HAVING (B)(6) INFECTION, WITH A SECONDARY BACTERIAL INFECTIONS. THE PATIENT WAS TREATED WITH ANTIPROTOZOAL, ANTIBIOTIC, AND ANTI-INFLAMMATORY THERAPY. AFTER ONE MONTH OF TREATMENT, THE CORNEAL ULCER HAD HEALED, AND THE PATIENT'S BEST CORRECTED VISUAL ACUITY WAS 20/100 OD AND 20/25 OS.

Additional Manufacturer Narrative

THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER AND NO LOT NUMBER INFORMATION WAS PROVIDED. HOWEVER, THE DOCTOR STATED THAT IRREGULAR CLEANING AND DISINFECTING OF LENSES, ALONG WITH THE USE OF TAP WATER DURING LENS CLEANING BY THE PATIENT, SEEMED TO HAVE CAUSED THE EVENT. BASED ON ALL INFORMATION, NO CAUSAL FACTORS CAN BE DETERMINED, AND NO CONCLUSION CAN BE DRAWN.