CLAREON MONARCH IV IOL DELIVERY SYSTEM, INJECTOR
Received Jul 12, 2026 · Event occurred May 6, 2026
Report 2523835-2026-00727 · MDR key 25790987
Device
Generic name
Folders And Injectors , Inraocular Lens (iol)
Manufacturer
Alcon Research, Llc - Alcon Precision DeviceModel number
IVCatalog number
8065977774
Lot number
ASKU
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
77 YR · Female
- Endophthalmitis
Narrative
Description of Event or Problem
A NON-HEALTH CARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, THE PATIENT EXPERIENCED BILATERAL ENDOPHTHALMITIS. THE PROCEDURE WAS COMPLETED ON THE SAME DAY. ADDITIONAL INFORMATION HAS BEEN REQUESTED, YET NO NEW INFORMATION RECEIVED. THERE ARE TWO MEDICAL REPORTS ASSOCIATED WITH SAME EVENT. THIS FILE BELONGS TO RIGHT EYE.
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.