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

Catalog Number	8065000334
Medical Device Problem Code	Suction Failure (4039)
Health Effect - Clinical Code	Intraocular Pressure Decreased (4468)
Date of Event	01/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A non healthcare professional reported that the fluidics module displayed an error code, aspiration could not function, valved cannulas were leaking and eye was too soft which was stabilized by perfluropropane (c3f8) and a syringe with thirty gauge needle during surgery.The procedure type was unknown.The procedure was completed.It was unknown about how the procedure was completed.There was no patient impact.Additional information has been requested.None received till date.This report pertains to cassette involved in reported event.
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.
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 sample was not received at the investigating site for this complaint report; visual inspection or functional testing could not be conducted.If a sample is returned at a later date, the investigation will be reopened and the sample evaluated.The root cause of the customer's complaint could not be established as a sample has not been received.Without a sample, it is not possible to isolate the root cause.As the root cause is unknown, the relationship, if any, of the device to the reported incident cannot be determined.After the investigation of this complaint, it has been determined that no action will be taken at this time as a sample was not returned.No adverse trends have been observed associated with the reported product and event.Quality assurance will continue to monitor customer complaints via the complaint review meetings and will take action for any future occurrences as is deemed necessary.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.

• Brand Name: UNITY TOTALPLUS POSTERIOR 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: 21400620
• Report Number: 1644019-2025-00472
• Device Sequence Number: 9455965
• Product Code: LRO
• UDI-Device Identifier: 00380650003348
• UDI-Public: (01)00380650003348(17)250930(11)241021(10)173430
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K880961
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/22/2025

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 Expiration Date: 09/30/2025
• Device Catalogue Number: 8065000334
• Device Lot Number: 173430
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/21/2025
• Supplement Date Received by Manufacturer: 03/27/2025
• Initial Report FDA Received Date: 02/18/2025
• Supplement Report FDA Received Date: 04/22/2025
• Date Device Manufactured: 10/21/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: UNITY VCS CONSOLE
• Patient Sex: Unknown