InjuryHMY
CBSU MICROKERATOME
Received Mar 17, 2025 · Event occurred Feb 27, 2025
Report 9615659-2025-00001 · MDR key 21624649
Device
Product problems
- Insufficient Device Problem Information
- Insufficient Device Problem Information
Patient
26 YR · Unknown
- Eye Injury
- Eye Injury
Narrative
Description of Event or Problem
HEALTHCARE PROVIDER REPORTED SMALL/INCOMPLETE FLAP ON RIGHT EYE. ALSO STATED: ABORTED SURGERY, WILL DO PRK IN 3-4 MONTHS; DID NOT SAVE BLADE; SENT FULL SYSTEM, AND CLINICAL DATA FOR EVALUATION.
Additional Manufacturer Narrative
ALTHOUGH THE MICROKERATOME SYSTEM TESTED ACCEPTABLE, THE CBSU BLADE WAS NOT SAVED AND THEREFORE NOT TESTED. THE LOT OF THE CB BLADE WAS LIKELY 2212103 (WHICH WAS THE LAST LOT SHIPPED TO THE CUSTOMER, BUT NOT CONFIRMED).