MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HOUSTON INFINITI SURGICAL PROCEDURE PAK; GENERAL SURGERY TRAY (KIT)

Catalog Number	8065751196
Medical Device Problem Code	Failure to Cut (2587)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/01/2023
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 physician reported that cutting and actuation failure of the cutter during cataract surgery.The surgery was completed after replacing the product with another one.There was no patient harm.
Additional Manufacturer Narrative
Two opened probes were received with tip protectors in a tray.Sample #1 was visually inspected and found to be non-conforming with the inner cutter in the port.Sample #1 was then functionally tested for actuation and cut and was found to be conforming for both functional tests.Sample #2 was visually inspected and found to be non-conforming with the inner cutter in the port and orange/brown foreign material on the inner cutter.Sample #2 was then functionally tested for actuation and cut.The sample was found to be conforming for actuation and was non-conforming for cut.Sample #2 was then disassembled and the components inspected.No/minimal wear was observed on the inner cutter when compared to the degree of wear based on continuous actuation of the probe visual standard photos.A couple gouge marks were observed at one location along the inner cutter.A review of the device history records traceable to the reported lot number indicates that the reported product was processed and released according to the reported product¿s acceptance criteria.The complaint evaluation does not confirm that sample #1 had actuation or cut failures.The evaluation did not confirm that sample #2 had an actuation failure but does confirm that sample #2 had a cut failure.The exact cause of the cut failure cannot be determined from the evaluation performed.The reported actuation failure was not confirmed in either sample, the reported cut failure was not confirmed in sample #1, and the exact root cause of the cut failure in sample #2 could not be determined; therefore, no specific action with regard to this complaint was taken by the manufacturing site.All probes are 100% visually inspected and tested for actuation, aspiration, and cut during manufacturing.Complaints will be continued to be reviewed and monitored at regular intervals for any significant adverse trends.No adverse trends have been observed associated with the reported product and event.No further actions are required.The manufacturer internal reference number is: (b)(4).

• Brand Name: INFINITI SURGICAL PROCEDURE PAK
• Common Device Name: GENERAL SURGERY TRAY (KIT)
• Manufacturer (Section D): ALCON RESEARCH, LLC - HOUSTON; 9965 buffalo speedway; houston TX 77054
• Manufacturer (Section G): ALCON RESEARCH, LLC - HOUSTON; 9965 buffalo speedway; houston TX 77054
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 18271973
• Report Number: 1644019-2023-01771
• Device Sequence Number: 14454752
• Product Code: LRO
• UDI-Device Identifier: 00380657511969
• UDI-Public: 00380657511969
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K880961
• 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): 04/03/2024

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 Expiration Date: 07/31/2024
• Device Catalogue Number: 8065751196
• Device Lot Number: 1502PY
• 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: 11/12/2023
• Supplement Date Received by Manufacturer: 03/08/2024
• Initial Report FDA Received Date: 12/05/2023
• Supplement Report FDA Received Date: 04/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/29/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: INFINITI VISION SYSTEM
• Patient Sex: Unknown