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	11/06/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
A physician reported that an ophthalmic system exhibited system message during a cataract surgery.Surgery was cancelled and patient was transferred to another facility and it was completed.Patient condition is unknown.
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.A sample is available that has not yet been received at manufacturing for evaluation.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
The company representative was able to replicate the reported event.The footswitch was replaced to address the issue.The footswitch was returned for testing on this investigation.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 on this investigation.A visual inspection of the sample was conducted, and no visual nonconformities were observed.The sample was connected to a known-conforming console without cables (wireless mode) and the treadle was depressed up and down.System message was displayed on screen when the treadle was depressed up and down.Up-switches 1, 4, and 5 were always off when the treadle was back to home position.The bottom cover was removed to inspect the sample for any nonconformities and a foreign object was spotted under the treadle.Moisture was also present inside the footswitch.The foreign object was removed, and system message no longer appeared.The sample passed all other testing.The root cause of the reported events are attributed to the presence of a foreign object between the up-switch and the treadle.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: 18264240
• Report Number: 2028159-2023-01624
• Device Sequence Number: 7890568
• Product Code: HQC
• UDI-Device Identifier: 00380657517626
• UDI-Public: 00380657517626
• 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): 02/26/2024

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: 8065751762
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/06/2023
• Supplement Date Received by Manufacturer: 01/31/2024
• Initial Report FDA Received Date: 12/05/2023
• Supplement Report FDA Received Date: 02/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/11/2018
• 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