CENTURION Surgical Procedure Pak
Received Jul 28, 2026 · Event occurred Mar 23, 2026
Report 1644019-2026-04036 · MDR key 50051206
Device
Generic name
General Surgery Tray (kit)
Manufacturer
Alcon Research, Llc - HoustonModel number
NACatalog number
8065752201
Lot number
ASKU
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- Eye Burn
Narrative
Description of Event or Problem
A non-healthcare professional reported via health authority that patient experienced corneal burn to the left eye during surgery. Sutures were used to approximate the wound, and the surgery was completed on the same day. Patient was discharged from the hospital on the same day, and the current condition of the patient is unknown.Additional information was requested and none received till date.This report pertains to phacoemulsification tip involved in this 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.