inforMED
MalfunctionMSS

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)

Model number

NA

Catalog 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).