MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HOUSTON UNITY TOTAL PLUS COMBINED PROCEDURE PACK; GENERAL SURGERY TRAY (KIT)

Catalog Number	8065000485
Medical Device Problem Codes	Component Missing (2306); Improper Flow or Infusion (2954)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/24/2024
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).
Event or Problem Description
A physician reported that the fluid air exchange (fax) could not be installed properly and was found to have a missing o-ring on the connector before vitrectomy surgery.The procedure was completed by replacing the product with new one.There was no patient impact.
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.The customer did not retain a sample for this complaint report, visual inspect could not be conducted on the actual sample.However, the customer did provide a photo of fluid air exchange f/ax manifold which confirms that the o-ring was missing.The root cause of the customer's reported event was determined to be related to an error during the supplier¿s manufacturing process.The supplier has been made aware of the issue.However, as the occurrence rate for this failure is low and this appears to be an isolated incident, no formal root cause or corrective action will be requested at this time.No adverse trends have been observed associated with the reported product and event.Quality assurance will continue to monitor and will take action for future occurrences as deemed necessary.The manufacturer internal reference number is: (b)(4).

• Brand Name: UNITY TOTAL PLUS COMBINED PROCEDURE PACK
• 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: 20520445
• Report Number: 1644019-2024-02478
• Device Sequence Number: 12704080
• Product Code: LRO
• UDI-Device Identifier: 00380650004857
• UDI-Public: (01)00380650004857(17)250430(11)240513(10)16TF67
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K880961
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/04/2024

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: 04/30/2025
• Device Catalogue Number: 8065000485
• Device Lot Number: 16TF67
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/26/2024
• Supplement Date Received by Manufacturer: 11/12/2024
• Initial Report FDA Received Date: 10/24/2024
• Supplement Report FDA Received Date: 12/04/2024
• Date Device Manufactured: 05/13/2024
• 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