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

Catalog Number	8065000331
Medical Device Problem Code	Suction Problem (2170)
Health Effect - Clinical Code	Retinal Tear (2050)
Date of Event	07/15/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
A non-healthcare professional reported that during a vitrectomy procedure and ophthalmic vitrectomy, probe failed to build the aspiration.The vitreous was attached to the port resulted in traction on the retina and the surgeon had to perform laser treatment to repair the retina.An advisory message was also displayed during the procedure.The procedure was completed on the same day by replacing the product with another one.The current condition of the patient was unknown.Additional information has been requested and none received till date.
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).

• Brand Name: UNITY TOTAL PLUS 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 ; +1(800)757-9780
• MDR Report Key: 50172773
• Report Number: 1644019-2026-04216
• Device Sequence Number: 9880071
• Product Code: LRO
• UDI-Device Identifier: 00380650003317
• UDI-Public: (01)00380650003317(17)271231(11)260123(10)17VW8J
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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): 09/03/2026

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: 8065000331
• Device Lot Number: 17VW8J
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 07/15/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/07/2026
• Supplement Report FDA Received Date: 09/03/2026
• Date Device Manufactured: 01/23/2026
• 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
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Sex: Unknown