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

Catalog Number	8065750541
Medical Device Problem Code	Fitting Problem (2183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/05/2023
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 fluidics management system were not connected properly with irrigation/aspiration and phaco handpiece during surgery.The surgery was completed after replacing the product with new one.There was no patient harm.
Additional Manufacturer Narrative
A review of the device history record traceable to the reported lot number indicates that the product was processed and released according to the product¿s acceptance criteria.Two used fluidics management system (fms) were visually inspected.The samples were tested on a console.Sample one, the blue female fitting was not on the aspiration tubing in the returned condition.The distal end of the aspiration line did not show a machine straight cut, and was half an inch shorter than the irrigation line.Sample two, the ball in the drip chamber check valve moved freely per specification.The sample primed and tuned successfully.No message code, no fluid or air leaks were found on the cassette, and no defects were found.The irrigation and aspiration fittings were intact.No detachment occurred from the handpiece during tuning process.The aspiration and irrigation fittings (sample 1 and 2) could be connected firmly and securely on the handpiece.Sample two met specification; however for sample one the root cause is unknown.Although the luer was missing in the returned condition, the aspiration line was wet and there were marks on the tubing which suggests the luer was on the tubing at some point when the fms was being used.In addition, the witness marks on the tubing serves as proof that the luer was in fully in the tubing.In the returned condition, it is not possible to determine at what point the luer was removed/detached from the tubing.This complaint has been reviewed and it is determined that no further actions will be pursed at this time.Based on our current tracking, there are no adverse trends for this reported complaint.Quality assurance has reviewed this complaint and will continue to monitor data for evidence of adverse trending and take further action, as appropriate.The manufacturer internal reference number is: (b)(4).

• 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: 17468656
• Report Number: 1644019-2023-00997
• Device Sequence Number: 7493763
• Product Code: LRO
• UDI-Device Identifier: 00380657505418
• UDI-Public: 00380657505418
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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): 12/05/2023

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: 10/31/2024
• Device Catalogue Number: 8065750541
• Device Lot Number: 1564VY
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/11/2023
• Supplement Date Received by Manufacturer: 11/10/2023
• Initial Report FDA Received Date: 08/07/2023
• Supplement Report FDA Received Date: 12/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/28/2022
• 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
• Patient Sex: Unknown