MAUDE Adverse Event Report: ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER NGENUITY DIGITAL VISUALIZATION SYSTEM; MICROSCOPE, OPERATING & ACC., AC-POWERED, OPHTHALMIC

Catalog Number	8065753091
Medical Device Problem Code	Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	Capsular Bag Tear (2639)
Date of Event	12/04/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
A physician reported that an ophthalmic visualization system 3d screen turned double suddenly and the patient had posterior capsule rupture during aspiration step of cataract surgery.The situation of the double was resolved as soon as changing to the keyboard operation, the screen backed to the 3d.The surgery was completed on the same day.
Additional Manufacturer Narrative
Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
Service history was reviewed for the system.No service record relevant to the complaint reported event was found.However, the system was last serviced prior to the reported event per service record (sr) opened.The system found to meet all cosmetic and performance standards.However, the event logs were provided for review.A non-conformance based review of the serial number was performed and did not reveal any potential contributing factors to the reported complaint.A manufacturing device history record (dhr) review was performed prior to product release to ensure that the product was manufactured in compliance with the device master record.Based on the assessment, the product met release criteria.A review for complaints reported against this serial number was performed.Potentially relevant complaints were found and reviewed as part of this investigation.The complaints were determined to not be relevant to this investigation.Despite the system meeting specification, the event logs were analyzed.It was determined that the ¿2d to 3d issue¿ is consistent with a software update.The reported ¿capsular rupture¿ cannot be conclusively determined, based upon the information obtained.The root cause of the reported 3d to 2d drop is attributed to the software upgrade issue.Posterior capsule tear is an issue that is occasionally reported with cataract surgery.However, a review of the complaint trends shows that the frequency reported is within known levels for this event.The reported ¿capsular rupture¿ cannot be conclusively determined, based upon the information obtained.Manufacturer will continue to monitor data for evidence of adverse trending and take further action, as appropriate.The manufacturer internal reference number is: (b)(4).

• Brand Name: NGENUITY DIGITAL VISUALIZATION SYSTEM
• Common Device Name: MICROSCOPE, OPERATING & ACC., AC-POWERED, OPHTHALMIC
• Manufacturer (Section D): ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER; 15800 alton parkway; irvine CA 92618
• Manufacturer (Section G): ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER; 15800 alton parkway; irvine CA 92618
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 18408231
• Report Number: 2028159-2023-01724
• Device Sequence Number: 14121506
• Product Code: EPT
• UDI-Device Identifier: 00380657530915
• UDI-Public: 00380657530915
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/25/2024

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 Catalogue Number: 8065753091
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/04/2023
• Supplement Date Received by Manufacturer: 02/29/2024
• Initial Report FDA Received Date: 12/28/2023
• Supplement Report FDA Received Date: 03/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Other
• Patient Sex: Unknown