MAUDE Adverse Event Report: CARL ZEISS MEDITEC AG (OBERKOCHEN) QUATERA 700; OPHTHALMIC, ANESTHESIA, RESPIRATORY, ENT AND DENTAL DEVICES OPHTHALMIC DEVICES

Model Number N/A

Device Problem Use of Device Problem (1670)

Patient Problem Capsular Bag Tear (2639)

Event Date 08/09/2022

Event Type  Injury  

Event Description

During surgery, the phaco portion of the procedure went as planned after a femto second laser performed lens fragmentation and capsulotomy.During the irrigation and aspiration portion of the procedure, the anterior capsule incurred a slight tear as a result of the i/a handpiece nicking the anterior capsule.The patient received a 3 piece iol implanted in the sulcus.

Manufacturer Narrative

Based on the information reviewed, there is no evidence to indicate the presence of a potential quality issue with respect to manufacturing, design or labeling.Furthermore, this incident was caused by a user error, which was not due to ergonomic features, as well as any inadequacy in the information supplied by the manufacturer.There is no sign for a systematic failure.

• Brand Name: QUATERA 700
• Type of Device: OPHTHALMIC, ANESTHESIA, RESPIRATORY, ENT AND DENTAL DEVICES OPHTHALMIC DEVICES
• Manufacturer (Section D): CARL ZEISS MEDITEC AG (OBERKOCHEN); rudolf-eber-strasse 11; oberkochen, baden-wuerttemberg 73447 ; GM 73447
• Manufacturer (Section G): CARL ZEISS MEDITEC AG (OBERKOCHEN); rudolf-eber-strasse 11; oberkochen, baden-wuerttemberg 73447 ; GM 73447
• Manufacturer Contact: manjaya hegde ; 5300 central parkway; dublin, CA 94568 ; 9252164697
• MDR Report Key: 15375442
• MDR Text Key: 299447061
• Report Number: 9615010-2022-00007
• Device Sequence Number: 1
• Product Code: HQE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K212241
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 09/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 000000-2521-048
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/14/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/03/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention