PARAGON CRT 100
Received Jan 8, 2026 · Event occurred Jan 1, 2025
Report 3013398957-2026-12273 · MDR key 24012239
Device
Generic name
Lens, Contact, Orthokeratology, Overnight
Manufacturer
Paragon Vision Sciences, Inc.Product problems
- Inadequacy of Device Shape and/or Size
- Patient-Device Incompatibility
- Adverse Event Without Identified Device or Use Problem
Patient
NA · Unknown
- Corneal Abrasion
Narrative
Description of Event or Problem
PATIENT HAD A CORNEAL ABRASION IN THE RIGHT EYE. PATIENT DID WASH OUT AND HE NEEDED A CRTDA LENS, NOT A CRT 100. THE PATIENT WAS WEARING THE LENS SINCE (B)(6) 2025. THEY STOPPED WEARING THEM 5 WEEKS AGO. THE VISION WAS STILL 20/30 THROUGH THE CENTRAL ABRASION. MAXITROL WAS PRESCRIBED UNTIL THE ABRASION HEALED ONE DROP TID, FOR 2 WEEKS. AND THEN ATS WERE USED UNTIL THE FINAL SPK FULLY DISSIPATED. NOTHING ELSE FOR THE TREATMENT WAS REQUIRED. THE TREATMENT WAS ADMINISTERED IN THE OFFICE. THE PATIENT HAS RECOVERED. VISUAL ACUITY IS BACK TO NORMAL AND CORNEA IS CLEAR. THEY ARE GOING TO SCHEDULE A FOLLOW UP WHEN THE NEW DUAL AXIS CONTACT COMES IN.
Additional Manufacturer Narrative
THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR THE INVESTIGATION. REVIEW OF THE DEVICE HISTORY RECORD FOUND THAT THE QUALITY CONTROL (QC) BATCH MET RELEASE REQUIREMENTS AT THE TIME OF MANUFACTURE.
Remedial action
- Replace