MAUDE Adverse Event Report: Alcon Research, LLC - Irvine Technology Center UNITY Vision System, Accessory, Active Sentry Handpiece; Unit, phacofragmentation

Catalog Number	8065752914
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Corneal Edema (1791); Blurred Vision (2137); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	07/08/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
A physician reported that, following cataract surgeries performed using an ophthalmic system and ophthalmic handpieces, multiple patients experienced significant corneal edema and swelling on postoperative day one.The physician stated that all 16 patients evaluated on the first postoperative day presented with significant corneal edema, reduced visual acuity of 20/100 or worse, at least 1+ descemet¿s folds, and 1+ microcystic edema.The patients' current condition is unknown.The physician further reported that the ophthalmic system and handpieces successfully passed prime and tune testing, and no advisory codes were generated.It was reported that there was no indication that these handpieces were used in the procedures.This report pertains to the fourth of twelve different handpieces reported from the same facility.
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.

• Brand Name: UNITY Vision System, Accessory, Active Sentry Handpiece
• Common Device Name: Unit, phacofragmentation
• Manufacturer (Section D): Alcon Research, LLC - Irvine Technology Center; 15800 alton parkway; irvine CA 92618
• Manufacturer (Section G): Alcon Research, LLC - Irvine Technology Center; 15800 alton parkway; irvine CA 92618
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; +1(800)757-9780
• MDR Report Key: 50756250
• Report Number: 2028159-2026-01449
• Device Sequence Number: 9195314
• Product Code: HQC
• UDI-Device Identifier: 00380657529148
• UDI-Public: (01)00380657529148(17)350129(11)250131(10)1785WE
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K233876
• 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
• Report Date (Section B): 09/14/2026

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: 8065752914
• Device Lot Number: 1785WE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 08/19/2026
• Initial Report FDA Received Date: 09/14/2026
• Date Device Manufactured: 01/31/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNITY VCS Console.
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown