QUATERA 700
Received May 2, 2025 · Event occurred Apr 2, 2025
Report 9615010-2025-00007 · MDR key 21955223
Device
Generic name
Microscope, Surgical, General & Plastic Surgery
Manufacturer
Carl Zeiss Meditec Ag (oberkochen)Catalog number
6407
Product problems
- Temperature Problem
- Temperature Problem
Patient
NA · Unknown
- Eye Burn
- Eye Burn
Narrative
Description of Event or Problem
A CUSTOMER IN PANAMA REPORTED A CORNEAL BURN DUE TO PROBLEMS WITH THE COMPRESSOR CONSOLE. IT WAS NECESSARY TO PUT A CORNEAL PATCH, AND NO FURTHER MEDICAL INTERVENTION IS NEEDED. THE PLANNED IOL WAS SUCCESSFULLY IMPLANTED.
Additional Manufacturer Narrative
THE PRIMARY ROOT CAUSE OF THE INCIDENT APPEARS TO BE USER ERROR, SPECIFICALLY THE EXCESSIVE USE OF ULTRASOUND ENERGY LEADING TO CORNEAL BURN. THE INSTRUCTIONS FOR USE (IFU) STATES CLEARLY THE ACTIONS TO BE TAKEN TO AVOID APPLICATION OF EXCESSIVE USE OF ULTRASOUND ENERGY. WHILE LEAKAGE IN THE CONSOLE PATH AND A WEAK CONSOLE PUMP WERE IDENTIFIED, THEY DID NOT CONTRIBUTE TO THE CORNEAL BURN AS THE DEVICE'S SAFETY MECHANISMS WOULD DEACTIVATE SURGICAL FUNCTIONS IN SUCH SCENARIOS. B4: ADDED DATE OF THIS REPORT G3: ADDED "DATE RECEIVED BY MANUFACTURER" G6: TYPE OF REPORT, SELECTED "30-DAY" AND "FOLLOW-UP" H2: IF FOLLOW-UP, WHAT TYPE? SELECTED "ADDITIONAL INFORMATION", AND "DEVICE EVALUATION". H3: UPDATED TO "YES" H6: ADDED TYPE OF INVESTIGATION "10, TESTING OF ACTUAL/SUSPECTED DEVICE". UPDATED INVESTIGATION FINDINGS TO "4248 USAGE PROBLEM IDENTIFIED". UPDATED INVESTIGATION CONCLUSIONS TO '19-CAUSE TRACED TO USER".