QUATERA 700
Received Dec 22, 2023 · Event occurred Dec 5, 2023
Report 9615010-2023-00017 · MDR key 18386044
Device
Generic name
Ophthalmic, Anesthesia, Respiratory, Ent And Dental Devices Ophthalmic Device
Manufacturer
Carl Zeiss Meditec Ag (oberkochen)Model number
6407Product problems
- Use of Incorrect Control/Treatment Settings
- Use of Incorrect Control/Treatment Settings
Patient
Unknown
- Eye Injury
- Eye Injury
Narrative
Description of Event or Problem
A HEALTH CARE PROFESSIONAL (HCP) REPORTED THAT THE USER SETTINGS FROM LAST CASE DID NOT RESET BACK TO DEFAULT VALUES. THEREFORE, THE NEXT SURGERY WAS EXECUTED WITH THE WRONG SETTINGS RESULTING IN A POSTERIOR CAPSULE RUPTURE. ISSUE OCCURRED DURING PHACOEMULSIFICATION CATARACT EXTRACTION AND IOL INSERTION. THERE WAS A 15-30 MINUTE INTRAOPERATIVE DELAY DUE TO ANTERIOR VITRECTOMY. THE LENS INTENDED FOR THE PROCEDURE WAS INSERTED.
Additional Manufacturer Narrative
THE ROOT CAUSE OF THE REPORTED EVENT WAS USER ERROR AS THE USER HAS TO CHECK THE SETTINGS BEFORE EVERY USE. THE IFU DESCRIBES SUFFICIENTLY THAT WRONG SETTINGS COULD LED TO AN INJURY. CHANGING THE SETTINGS BACK TO DEFAULT SETTINGS HAS TO BE EXECUTED MANUALLY BY THE USER.