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

Catalog Number	8065000138
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	Rupture (2208)
Date of Event	03/20/2023
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 wrench pieces like yellow, sharp slivers were found in the eye and removed during the cataract surgery.During the surgery, the patient had a torn capsule.The surgery was completed.Additional information was requested; however, none has been received to date.
Event or Problem Description
A customer reported that wrench pieces like yellow, sharp slivers were found in the eye and removed during the cataract surgery.During the surgery, the patient had a torn capsule.The surgery was completed.Additional information requested and received that patient was recovered.
Additional Manufacturer Narrative
One open phacoemulsification (phaco) wrench in a small parts tray was received.The sample was visually inspected and was found to be non-conforming; the wrench was damaged with push plastic with pieces of plastic still attached but broken away from the inner diameter walls.There were stress cracks observed on the wrench.A review of the device history record 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 confirms damaged to the wrench with pushed plastic with pieces of plastic still attached but broken away.How and when the wrench became damaged cannot be determined from this evaluation, therefore the root cause cannot be determined.A possible contributing factor for the plastic foreign material could occur during placing the phaco tip onto the handpiece using the plastic phaco tip wrench.An investigation has been completed and actions are presently being implemented to eliminate the foreign material issues with the phaco tip and plastic wrench.An acceptance quality limit (aql) sampling is performed to ensure that the wrenches meet release acceptance criteria.All phaco tips are 100% visually inspected by trained operators using 30x magnification during the manufacturing process.Any nonconformance is removed from the lot and scrapped, this inspection includes foreign material.Complaints are reviewed and monitored at regular intervals for any significant adverse trends.The manufacturer internal reference number is: (b)(4).

• Brand Name: CENTURION 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: 16794584
• Report Number: 1644019-2023-00454
• Device Sequence Number: 12480250
• Product Code: LRO
• UDI-Device Identifier: 00380650001382
• UDI-Public: 00380650001382
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K880961
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/27/2023

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 Expiration Date: 10/31/2024
• Device Catalogue Number: 8065000138
• Device Lot Number: 1565RE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/27/2023
• Supplement Date Received by Manufacturer: 06/30/2023
• Initial Report FDA Received Date: 04/24/2023
• Supplement Report FDA Received Date: 07/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/18/2022
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown