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

Model Number 6407

Device Problem Use of Incorrect Control/Treatment Settings (1126)

Patient Problem Eye Injury (1845)

Event Date 12/05/2023

Event Type  Injury  

Event Description

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.

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.

• Brand Name: QUATERA 700
• Type of Device: OPHTHALMIC, ANESTHESIA, RESPIRATORY, ENT AND DENTAL DEVICES OPHTHALMIC DEVICE
• 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: 18386044
• MDR Text Key: 331292210
• Report Number: 9615010-2023-00017
• Device Sequence Number: 1
• Product Code: FSO
• Combination Product (y/n): N
• Reporter Country Code: NZ
• PMA/PMN Number: K130549
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 6407
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/11/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/15/2020
• 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