MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D
Received May 8, 2026 · Event occurred Apr 14, 2026
Report 1119421-2026-00999 · MDR key 25124750
Device
Generic name
Folders And Injectors, Intraocular Lens (iol)
Manufacturer
Alcon Research, Llc - HuntingtonModel number
NACatalog number
8065977763
Lot number
ASKU
Product problems
- Device Damaged by Another Device
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING A CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE LENS WAS DAMAGED WHEN INSERTED INTO INJECTOR. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.
Additional Manufacturer Narrative
A PRODUCT WAS NOT RETURNED FOR ANALYSIS. COMPLAINT HISTORY AND PRODUCT HISTORY RECORD COULD NOT BE REVIEWED BECAUSE THE REPORTING FACILITY DID NOT PROVIDE A VALID LOT NUMBER OR ANY IDENTIFICATION TRACEABLE TO THE MANUFACTURING DOCUMENTATION. ROOT CAUSE HAS NOT BEEN IDENTIFIED. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).