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

Catalog Number	8065750541
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/03/2024
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).H.10 reflects all related report numbers associated with this product event that have been submitted at this time.
Event or Problem Description
A non-healthcare professional reported that water flow obstruction during cataract surgery with intraocular lens implant.After multiple tests, it took fifteen minutes to pass, delaying the surgery time.The surgery was completed on the same day.There was no patient impact.
Additional Manufacturer Narrative
Additional information provided in b.1.B.2.B.5.H.2.And h.11.Additional information received that the event timing was corrected from (during surgery to during calibration) for the event water flow obstruction.The manufacturer internal reference number is: (b)(4).H.10 reflects all related report numbers associated with this product event that have been submitted at this time.
Event or Problem Description
Additional information received that the event timing was corrected from (during surgery to during calibration) for the event water flow obstruction.

• Brand Name: LAUREATE 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: 21089234
• Report Number: 1644019-2025-00109
• Device Sequence Number: 8732141
• Product Code: LRO
• UDI-Device Identifier: 00380657505418
• UDI-Public: (01)00380657505418(17)280930(11)231005(10)16849W
• 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): 02/07/2025

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: 8065750541
• Device Lot Number: 16849W
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/15/2024
• Supplement Date Received by Manufacturer: 01/09/2025
• Initial Report FDA Received Date: 01/07/2025
• Supplement Report FDA Received Date: 02/07/2025
• Date Device Manufactured: 10/05/2023
• 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: LAUREATE WORLD PHACO SYSTEM.
• Patient Age: 71 YR
• Patient Sex: Female