MAUDE Adverse Event Report: Alcon Research, LLC - Houston UNITY Cataract FMS Procedure Pack; General surgery tray (kit)

Catalog Number	8065000339
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Anxiety (2328); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/26/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
A customer reported that there was display of error code during cataract surgery (with intra ocular lens implantation) surgery in the right eye of a male elderly patient.The incident resulted in prolonged delay in the start and progression of the surgical procedures causing anxiety and discomfort in patient requiring supplemental sedation and oxygen therapy, as well as delaying their postoperative discharge.Although inpatient admission was not required; management was outpatient-based and the patient was prescribed with topical ophthalmic drops per standard post-cataract surgery protocol.There was no negative consequences on the patient and the patient was recovering.This report pertains to one of the two cassettes involved in reported events.
Additional Manufacturer Narrative
The product was not received at the investigation site for this complaint report; visual inspection or functional testing could not be conducted.The customer provided a photo of the console screen with a system message code; however, without the product we are unable to confirm root cause.Clinical information review has been performed.The investigation conducted a non-conformance review of the reported lot number.No relevant deviations were identified, all corresponding production release specifications defined in the device master record were met.As the root cause and its origin are inconclusive, further investigation or manufacturing actions are not warranted at this time.Receipt of additional relevant information or supporting materials will prompt a re-evaluation of the complaint investigation.No further investigation or manufacturing actions are warranted at this time due to the product not being returned to the manufacturing site for testing.Receipt of additional relevant information or supporting materials will prompt a re-evaluation of the complaint investigation.Complaint data for all company products is reviewed monthly to monitor for adverse trends.During the last review, no adverse trends were observed for the reported product and event combination.Quality assurance has reviewed this complaint and will continue to monitor data for evidence of adverse trends and take further action, as appropriate.No further action warranted at this time.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 Cataract FMS 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 ; +1(800)757-9780
• MDR Report Key: 50194814
• Report Number: 1644019-2026-04241
• Device Sequence Number: 6098919
• Product Code: LRO
• UDI-Device Identifier: 00380650003393
• UDI-Public: (01)00380650003393(17)270630(11)250719(10)17J655
• Combination Product (Y/N): N
• Initial Reporter Country: AR
• 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
• Report Date (Section B): 08/10/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 8065000339
• Device Lot Number: 17J655
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 07/18/2026
• Initial Report FDA Received Date: 08/10/2026
• Date Device Manufactured: 07/19/2025
• 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: Hand Piece; UNITY TOTAL PLUS Combined Procedure Pack; UNITY VCS Console
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 62 YR
• Patient Sex: Male