PARAGON CRT DUAL AXIS

Additional Manufacturer Narrative

THE PRESCRIBED MEDICATIONS INCLUDE 0.3% GATIFLOXACIN OPHTHALMIC GEL, 0.1% FLUOROMETHOLONE EYE DROPS, AND BOVINE BASIC FIBROBLAST GROWTH FACTOR. ON (B)(6) 2026 PARAGON REQUESTED ADDITIONAL INFORMATION TO BETTER DETERMINE THE TYPE OF KERATITIS, INFORMATION HAS NOT BEEN RECEIVED. WITHOUT FURTHER CORNEAL INFORMATION, VISUAL OUTCOMES, AND DIAGNOSIS, THE MDR TEAM IS NOT ABLE TO ASSESS WHETHER THE PATIENT EXPERIENCED INFECTIOUS (MICROBIAL, VIRAL, FUNGAL) VS. NON-INFECTIOUS (CONTACT LENS RELATED RED EYE (CLARE), STERILE, DRY EYE-RELATED. THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR INVESTIGATION. REVIEW OF THE DEVICE HISTORY RECORD FOUND THAT THE QUALITY CONTROL (QC) BATCH MET RELEASE REQUIREMENTS AT THE TIME OF MANUFACTURE.

Description of Event or Problem

THE PATIENT WAS FITTED WITH ORTHOKERATOLOGY LENSES (CRT BRAND) AT THIS HOSPITAL ON (B)(6) 2025, DUE TO REFRACTIVE ERROR. THEY USED THEM ROUTINELY. ON (B)(6) 2025, THEY VISITED THE HOSPITAL AND WERE FOUND TO HAVE CONJUNCTIVAL HYPEREMIA IN THE RIGHT EYE, AND SCATTERED PATCHY OPACITIES AT THE LIMBUS AND CENTRAL CORNEA. THEY WERE DIAGNOSED WITH RIGHT KERATITIS AND DISCONTINUED WEARING THE LENSES, STARTING MEDICATION. ON (B)(6) 2025, THEY RETURNED FOR A FOLLOW-UP VISIT. THE RIGHT EYELID AND BULBAR CONJUNCTIVA WERE STILL HYPEREMIA, AND THERE WERE SCATTERED PATCHY OPACITIES AT THE LIMBUS AND CENTRAL CORNEA. THE DOCTOR INSTRUCTED THEM TO CONTINUE DISCONTINUING THE ORTHOKERATOLOGY LENSES AND CONTINUING MEDICATION, WITH A FOLLOW-UP VISIT IN 3-5 DAYS.