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

Catalog Number	8065751762
Medical Device Problem Code	Reflux within Device (1522)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/10/2023
Type of Reportable Event	Malfunction
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 before the cataract surgery an ophthalmic operating footswitch reflux function did not work.The surgery was completed on the same by replacing the footswitch.There is no patient harm.
Additional Manufacturer Narrative
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 lot/batch/serial number was performed.No similar complaints were reported for the product lot/batch/serial under investigation.Service history was reviewed for the system.Company representative (ar) performed an on-site assessment found cotton stuck in the left side toe switch.To resolve the issue, the ar cleaned the footswitch, performed service test procedure, and then found the machine to be working properly the root cause of the reported events are attributed to cotton being stuck in the left side toe switch, however, how or when the cotton entered the footswitch remains inconclusive.Actions taken per the sr resolved the reported events.This complaint has been reviewed and based on a low occurrence rate, it is determined that no further actions will be pursued at this time.Quality assurance has reviewed this complaint and will continue to monitor data for evidence of adverse trending and take further action, as appropriate.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information has been received with updated suspect product details.

• 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: 16885073
• Report Number: 2028159-2023-00660
• Device Sequence Number: 20356530
• Product Code: HQC
• UDI-Device Identifier: 00380657517626
• UDI-Public: 00380657517626
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K121555
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 8065751762
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/13/2023
• Supplement Date Received by Manufacturer: 07/11/2023
• Initial Report FDA Received Date: 05/08/2023
• Supplement Report FDA Received Date: 08/03/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: LEGION SYSTEM.
• Patient Sex: Unknown