PARAGON CRT 100
Received Apr 9, 2026 · Event occurred Mar 15, 2026
Report 3013398957-2026-12297 · MDR key 24831698
Device
Generic name
Lens, Contact, Orthokeratology, Overnight
Manufacturer
Paragon Vision Sciences, Inc.Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
NA · Unknown
- Corneal Ulcer
Narrative
Additional Manufacturer Narrative
THE CONTACT LENS WAS NOT RETURNED BY THE USER TO THE MANUFACTURER FOR EVALUATION. 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
ULCER PARACENTRAL OS. HEALED COMPLETELY PER DR. IT WAS REPORTED TO THE MANUFACTURER THAT THE PATIENT WORE THE LENS FOR 6 DAYS. THE VISUAL ACUITY WAS NOT AFFECTED, NO MEDICATION WAS PRESCRIBED. TREATMENT WAS CARRIED OUT IN THE OFFICE. PATIENT HAS RECOVERED. SCHEDULED A FOLLOW UP A WEEK AFTER THE NEW LENS ARRIVES.
Remedial action
- Replace