MAUDE Adverse Event Report: Alcon Research, LLC - Houston LEGACY Surgical Procedure Pak; General surgery tray (kit)

Catalog Number	8065750160
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/03/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A customer reported via health authority that the crack on the infusion cap of the phacoemulsification handle during cataract surgery with intraocular lens implant.The surgery was completed on same day after replacing the product with another one.There was no patient impact.
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).

• 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 ; +1(800)757-9780
• MDR Report Key: 50218818
• Report Number: 1644019-2026-04271
• Device Sequence Number: 16029509
• Product Code: LRO
• UDI-Device Identifier: 00380657501601
• UDI-Public: (01)00380657501601(17)261231(11)240104(10)16E7EW
• 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: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 08/12/2026

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: 8065750160
• Device Lot Number: 16E7EW
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 07/23/2026
• Initial Report FDA Received Date: 08/12/2026
• Date Device Manufactured: 01/04/2024
• 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