ACRYSOF IQ PANOPTIX TRIFOCAL IOL
Received Jul 22, 2026 · Event occurred Jun 29, 2026
Report 1119421-2026-01544 · MDR key 25903704
Device
Generic name
Lens, Multifocal
Manufacturer
Alcon Research, Llc - HuntingtonModel number
TFNT00Catalog number
TFNT00.230
Lot number
15592168
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- Visual Impairment
Narrative
Additional Manufacturer Narrative
A PRODUCT WAS NOT RETURNED FOR ANALYSIS. A DEVICE HISTORY RECORD REVIEW AND A NON-CONFORMANCE REVIEW OF THE REPORTED LOT NUMBER WAS CONDUCTED. THE DEVIATION REVIEW DID NOT REVEAL ANY POTENTIAL CONTRIBUTING FACTORS TO THE REPORTED COMPLAINT AND ALL CORRESPONDING PRODUCTION RELEASE SPECIFICATIONS DEFINED IN THE MEDICAL DEVICE FILE WERE MET. ROOT CAUSE HAS NOT BEEN IDENTIFIED. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).
Description of Event or Problem
A NURSE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE THE LENS WAS EXPLANTED WITH COMPANY LENS ON AN UNSPECIFIED DATE. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.