PARAGON CRT CONTACT LENS

Additional Manufacturer Narrative

THE LENSES WERE NOT RETURNED FOR INSPECTION. A FOLLOW UP WITH THE DOCTOR'S OFFICE INDICATED THE PATIENT IS FINE AND IS NOW WEARING SOFT CONTACT LENSES. SINCE THE PATIENT DID NOT WANT THE LENSES TO BE REPLACED, PARAGON ISSUED CREDIT FOR THE LENSES. A REVIEW OF THE DEVICE'S DHR FOUND THE LENS MET OUR RELEASE REQUIREMENTS AT THE TIME OF MANUFACTURE. NO FURTHER ACTION IS REQUIRED SINCE MICROBIAL KERATITIS IS A WELL-KNOWN RIKS WHEN WEARING ANY OVERNIGHT CONTACT LENS. THIS RISK IS DOCUMENTED IN PARAGON'S LABELING.

Description of Event or Problem

PATIENT STARTED USING PARAGON CRT LENSES IN (B)(6) 2018. INITIALLY THE PATIENT USED IMPROPER CARE AND HANDLING TECHNIQUES INCLUDING SOLUTION STORAGE. IN (B)(6), THE DOCTOR REPORTED THE PATIENT HAD IMPROVED THE CARE OF THE LENSES. NO ULCER WAS NOTED DURING THE (B)(6) DOCTOR'S VISIT. IN (B)(6) 2019, THE PATIENT COMPLAINED OF PAIN AND THE DOCTOR OBSERVED A CORNEAL ULCER WHICH REQUIRED MEDICAL INTERVENTION WITH EYE DROPS/ANTIBIOTICS. THE DOCTOR DISCONTINUED THE PATIENT'S WEAR OF PARAGON CRT AND THE ULCER RESULTED IN A CORNEAL SCAR. TO DATE, THE PATIENT'S OCULAR HEALTH IS STABLE, AND VISION IS GOOD AND UNAFFECTED BY THE SCAR. THE PATIENT IS WEARING SOFT CONTACT LENSES.