CLAREON MONARCH IV IOL DELIVERY SYSTEM, INJECTOR
Received Apr 2, 2026 · Event occurred Dec 11, 2025
Report 2523835-2026-00348 · MDR key 24769359
Device
Generic name
Folders And Injectors , Inraocular Lens (iol)
Manufacturer
Alcon Research, Llc - Alcon Precision DeviceModel number
IVCatalog number
8065977774
Lot number
152AX3
Product problems
- Inaccurate Delivery
- Device Damaged by Another Device
- Material Twisted/Bent
Patient
Unknown
- Insufficient Information
Narrative
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.
Description of Event or Problem
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANTATION SURGERY IT WAS OBSERVED THAT ALL FOUR HANDPIECES FAILED TO ENGAGE PROPERLY WITH THE LENS. THE SURGERY WAS COMPLETED ON THE SAME DAY. ADDITIONAL INFORMATION RECEIVED THAT THE ISSUE WITH FIVE HANDPIECES.
Additional Manufacturer Narrative
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.
Description of Event or Problem
THE LENS WAS DAMAGED BY HANDPIECE INJECTOR.