MAUDE Adverse Event Report: CARL ZEISS MEDITEC AG (OBERKOCHEN) OPMI LUMERA 700; MICROSCOPE, SURGICAL, GENERAL & PLASTIC SURGERY

Model Number	N/A
Medical Device Problem Code	Optical Obstruction (3002)
Health Effect - Clinical Code	Capsular Bag Tear (2639)
Date of Event	11/15/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Further analysis by the manufacturer revealed that if the double iris diaphragm fails, the entire performance of the depth of field should not be lost.The displayed image can only become extremely dark with insufficient lighting or unfavorable physiology of the eye.This can be corrected by adjusting the illuminance, selecting a lower magnification or refocusing.Therefore, the capsule ruptures described must necessarily be linked to the malfunction of the double iris diaphragm.The capsule rupture can also be due to pathological reasons or handling errors.Information on the case suggest a user error because: an instrument was used despite restricted vision.Reported conditions such as blur could have been corrected by adjusting the illumination, choosing a lower magnification or refocusing.The ifu clearly states not to use the instrument in case errors occur that cannot be fixed.
Event or Problem Description
A customer reported capsule rupture of a patient during cataract surgery due to dark and blurred view with a lack of depth of field through the eyepieces.As a result of the event, a sulcus fixed hkl had to be inserted due to the anterior capsule defect.

• Brand Name: OPMI LUMERA 700
• Common Device Name: MICROSCOPE, SURGICAL, GENERAL & PLASTIC SURGERY
• 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: 18361038
• Report Number: 9615010-2023-00015
• Device Sequence Number: 8108921
• Product Code: HRM
• UDI-Device Identifier: 04049539066343
• UDI-Public: (01)04049539066343
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: N/A
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 000000-2306-382
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/23/2023
• Initial Report FDA Received Date: 12/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/22/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown