MAUDE Adverse Event Report: ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER CENTURION VISION SYSTEM, FOOTSWITCH; UNIT, PHACOFRAGMENTATION

Catalog Number	8065751762
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	09/11/2024
Type of Reportable Event	Serious Injury
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).
Event or Problem Description
A physician reported that during surgery, an ophthalmic system error message was displayed and could not be used.The incision on the patient eye had already started and foot switch completely stopped working.The surgery was cancelled, patient return to the ward and reoperation was considered.Outcome of the patient was not reported.
Additional Manufacturer Narrative
Additional information is provided in sections d.9, h.3, h.6 and h.11.The company representative was able to replicate the reported event.The nonconforming footswitch was replaced under warranty, to address the issue.The footswitch was then, returned for testing.The system was tested and found to meet product specifications.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.No similar complaints were reported for the product serial under investigation.The footswitch was received for testing.A visual assessment of the returned sample revealed that screw was missing.During testing, the sample was seen to successfully wirelessly connected to a hotbed console.When depressing and releasing the footswitch, sm was displayed intermittently on the console screen, where it was seen that up switch 1 and 5 stayed off when the treadle traveled back to the home position.The bottom cover of the sample was removed, and it was noticed that a component was defective.This printed circuit board (pcb) was then replaced with a known-working pcb.Following this, the sm was no longer observed.The component failure was confirmed.The system met specification during installation, and then was non-conforming during the first case.How or why the component became non-conforming cannot be determined conclusively.The component failure was confirmed.The system met specification during installation, and then was non-conforming during the first case.How or why the component became non-conforming cannot be determined conclusively.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: CENTURION VISION SYSTEM, FOOTSWITCH
• Common Device Name: UNIT, PHACOFRAGMENTATION
• 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: 20389798
• Report Number: 2028159-2024-01529
• Device Sequence Number: 12403855
• Product Code: HQC
• UDI-Device Identifier: 00380657517626
• UDI-Public: (01)00380657517626(17)340202(11)240205(10)16HYNX(21)2401249843X
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K121555
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/08/2025

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: 8065751762
• Device Lot Number: 16HYNX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/10/2024
• Supplement Date Received by Manufacturer: 12/12/2024
• Initial Report FDA Received Date: 10/07/2024
• Supplement Report FDA Received Date: 01/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/05/2024
• 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; Required Intervention
• Patient Sex: Male