UNITY VCS Console
Received Jul 31, 2026 · Event occurred Jun 18, 2026
Report 2028159-2026-01180 · MDR key 50096000
Device
Generic name
Unit, Phacofragmentation
Manufacturer
Alcon Research, Llc - Irvine Technology CenterModel number
NACatalog number
8065000296
Lot number
17KHTV
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
Unknown
- Corneal Edema
- Corneal Scar
- Blurred Vision
Narrative
Description of Event or Problem
A physician reported that the patient experienced corneal edema of mild to moderate severity following cataract surgery with intraocular implantation. The patient also experienced mild corneal opacity. The corneal edema persisted for approximately 5 days and showed progressive improvement with the prescribed corticosteroid therapy. There was an initial postoperative reduction in best corrected visual acuity (BCVA) of more than 2 lines. No surgical intervention was required. Current patient outcome is recovered.This report pertains to ophthalmic system used for the first of five patients treated at 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.