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

Catalog Number	8065750517
Medical Device Problem Codes	Break (1069); Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/28/2023
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 non healthcare professional reported that foot switch cable aged causing valve damage and inability to perfusion during cataract surgery.The surgery was completed after replacing the foot pedal.There was no report of patient harm.
Additional Manufacturer Narrative
As a result of an internal review of the file, it was determined that the reported product issue foot switch cable aged causing valve damage and inability to perfusion does not represent a reportable malfunction as per applicable medical device regulations.There is no evidence of a life-threatening injury/illness or permanent impairment/damage, there has been no medical or surgical intervention to preclude permanent impairment/damage and the information provided does not represent a product problem that is likely to cause the above-mentioned events if the product problem were to recur.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
As a result of an internal review of the file, it was determined that the reported product issue foot switch cable aged causing valve damage and inability to perfusion does not represent a reportable malfunction as per applicable medical device regulations.There is no evidence of a life-threatening injury/illness or permanent impairment/damage, there has been no medical or surgical intervention to preclude permanent impairment/damage and the information provided does not represent a product problem that is likely to cause the above-mentioned events if the product problem were to recur.

• Brand Name: LEGACY 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: 18396128
• Report Number: 1644019-2023-01940
• Device Sequence Number: 19507874
• Product Code: LRO
• UDI-Device Identifier: 00380657505173
• UDI-Public: 00380657505173
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K880961
• 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): 03/11/2024

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: 01/31/2023
• Device Catalogue Number: 8065750517
• Device Lot Number: 2364719H
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/03/2023
• Supplement Date Received by Manufacturer: 02/21/2024
• Initial Report FDA Received Date: 12/27/2023
• Supplement Report FDA Received Date: 03/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/24/2020
• 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
• Patient Sex: Unknown