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

Catalog Number	8065751762
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Key or Button Unresponsive/not Working (4063)
Health Effect - Clinical Codes	Corneal Edema (1791); Unspecified Eye / Vision Problem (4471)
Date of Event	09/20/2023
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 customer reported that an ophthalmic foot pedal did not respond during surgery, the patient¿s eye was open for so long, a lot of corneal edema developed, which resulted in very limited vision.The procedure details was not reported.The current outcome of the patient was unknown.Additional information has been requested and non received till date.
Additional Manufacturer Narrative
Additional information provided in sections h.6.And h.10.There was no service has been requested by the customer in response to the reported event.Therefore, an onsite assessment of the product was not performed.Based on the information available, the customer reported event cannot be confirmed.A non-conformance based review of the batch/lot/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 customer reported event cannot be confirmed.Based on the information obtained, the root cause of the reported event is inconclusive.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).
Additional Manufacturer Narrative
The footswitch was received for testing on this investigation.A visual assessment of the returned sample revealed no obvious nonconformity.The footswitch was installed into a calibrated system and turned on.Functional testing confirmed the reported event.The returned footswitch was defective because of a cold solder at j1 connector of the footswitch dome up-switch pcb.The root cause of the reported ¿system message code being displayed¿ is attributed to a cold solder at j1 connector of the footswitch dome up-switch pcb.The root cause of the reported ¿corneal edema/limited vision¿ cannot be conclusively determined, based upon the information provided to date.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).
Additional Manufacturer Narrative
The fda product problem code has been updated from 2993 to 4063.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: 18092035
• Report Number: 2028159-2023-01537
• Device Sequence Number: 12451191
• Product Code: HQC
• UDI-Device Identifier: 00380657517626
• UDI-Public: 00380657517626
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 04/04/2024

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
• Device Lot Number: 14MN94
• 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: 10/18/2023
• Supplement Date Received by Manufacturer: 11/30/2023; 03/05/2024; 04/02/2024
• Initial Report FDA Received Date: 11/08/2023
• Supplement Report FDA Received Date: 12/26/2023; 04/02/2024; 04/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/03/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: CENTURION VISION SYSTEM (ACTIVE SENTRY)
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown