QUATERA 700
Received Apr 25, 2025 · Event occurred Mar 25, 2025
Report 9615010-2025-00006 · MDR key 21911450
Device
Generic name
Microscope, Surgical, General & Plastic Surgery
Manufacturer
Carl Zeiss Meditec Ag (oberkochen)Product problems
- Suction Problem
- Suction Problem
Patient
NA · Unknown
- Capsular Bag Tear
- Capsular Bag Tear
Narrative
Description of Event or Problem
A CUSTOMER IN NEW ZEALAND REPORTED THAT DURING A PROCEDURE WITH QUATERA 700, DURING IRRIGATION/ASPIRATION, THE VACUUM REMAINS ON EVEN WHEN HE WITHDRAWS HIS FOOT FROM THE FOOT PEDAL. THIS CAUSED A CAPSULAR TEAR FOR ONE OF HIS PATIENTS. THE PLANNED LENS WAS NOT IMPLANTED; THE PATIENT RECEIVED A 3-PIECE IOL DUE TO DAMAGE TO THE CAPSULAR BAG.
Additional Manufacturer Narrative
DESCRIPTION OF CHANGES: G3: ADDED "DATE RECEIVED BY MANUFACTURER" G6: TYPE OF REPORT, SELECTED "30-DAY" AND "FOLLOW-UP" H2: IF FOLLOW-UP, WHAT TYPE? , SELECTED "DEVICE EVALUATION". H3: UPDATED DEVICE EVALUATED BY MANUFACTURER TO "YES". H6: ADDED TYPE OF INVESTIGATION "10, TESTING OF ACTUAL/ SUSPECTED DEVICE" AND "4121, EVEN HISTORY LOG REVIEW". UPDATED INVESTIGATION FINDINGS TO " 104, SOFTWARE PROBLEM IDENTIFIED". UPDATED INVESTIGATION CONCLUSIONS TO"12, CAUSE TRACED TO DEVICE DESIGN".