CBSU MICROKERATOME
Received Dec 23, 2022 · Event occurred Jan 23, 2023
Report 9615659-2022-00002 · MDR key 16042429
Device
Generic name
Cbsu Microkeratome
Manufacturer
Moria SaModel number
19309/0, 19309/-1Catalog number
19309/0, 19309/-1
Lot number
N/A
Product problems
- Adverse Event Without Identified Device or Use Problem
- Failure to Clean Adequately
- Adverse Event Without Identified Device or Use Problem
- Failure to Clean Adequately
Patient
Unknown
- Keratitis
- Keratitis
Narrative
Additional Manufacturer Narrative
ALTHOUGH A CLEANING ISSUE IS IDENTIFIED, DLK IS POSSIBLY AN ENVIRONMENTAL ISSUE AND THEREFORE CONCLUSION CAN NOT BE ESTABLISHED.
Description of Event or Problem
HEALTHCARE PROVIDER REPORTED GETTING DLK. LAST TWO MONTHS OF SURGERIES GETTING COUPLE CASES EVERY ROUND OF SURGERIES. HEALTHCARE PROVIDER SENT IN (2) TURBINES & (4) RINGS (2 EA 19309/0 & 19309/-1) FOR EVALUATION; DOES NOT SEE VISIBLE RUST BUT WANTS INSPECTION. HEALTHCARE PROVIDER REVIEWING POSSIBLE ENVIRONMENTAL CAUSES: OR FILTERS & VENTS; INSTRUMENT CLEANING PROTOCOL; OFFICE MOLD; HVAC SYSTEM; ETC.
Description of Event or Problem
SUPPLEMENTAL / FOLLOW-UP REPORT TO 9615659-2022-00002. HEALTHCARE PROVIDER REPORTED OFFICE WAS TREATED FOR MOLD CONTAMINATION AND SWITCHED STERILIZER FROM DRY HEAT BACK TO AUTOCLAVE. DLK ISSUE IS NOW SIGNIFICANTLY BETTER; NOW EXPERIENCING ONLY OCCASIONAL MILD DLK TO PERIPHERY OF FLAP. HEALTHCARE PROVIDER SENT IN (4) RINGS (2 EA 19309/0 & 19309/-1) FOR EVALUATION.
Additional Manufacturer Narrative
2/20/23 HEALTHCARE PROVIDER STATED DLK ISSUE IS NOT RESOLVED AND WILL CONTINUE TO LOOK INTO ADDITIONAL ENVIRONMENTAL SOLUTIONS. DLK CAN BE CAUSED BY MANY FACTORS NOT ESPECIALLY LINKED TO MORIA MEDICAL DEVICES. A DOCUMENT "COMPLICATIONS OF LASIK, PART 3 - DIFFUSE LAMELLAR KERATITIS" WAS SENT TO THE HEALTHCARE PROVIDER.