FDA Adverse Event
Malfunction
Summary report: N
MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D
MDR report key: 24331503
·
Received February 13, 2026
Report
- Report Number
- 1119421-2026-00313
- Event Type
- Malfunction
- Date Received
- February 13, 2026
- Report Date
- February 13, 2026
- Manufacturer
- ALCON RESEARCH, LLC - HUNTINGTON
- Product Code
- MSS
- UDI-DI
- 00380659777639
- PMA / PMN Number
- K063155
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
A PRODUCT WAS NOT RETURNED FOR ANALYSIS. COMPLAINT HISTORY AND PRODUCT HISTORY RECORDS WERE REVIEWED AND DOCUMENTATION INDICATED THE PRODUCT MET RELEASE CRITERIA. ROOT CAUSE HAS NOT BEEN IDENTIFIED. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).
Description of Event or Problem · 0
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, CARTRIDGES HAVE BEEN SPLINTERING AS IOL IS ADVANCED THROUGH THE OPENING. THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 395088 | MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D | FOLDERS AND INJECTORS, INTRAOCULAR LENS (IOL) | MSS | ALCON RESEARCH, LLC - HUNTINGTON | NA | 16154907 | 00380659777639 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | CLAREON MONARCH IV IOL DELIVERY SYSTEM INJECTOR| CLAREON VIVITY EXTENDED VISION UV ABSORBING IOL| MONARCH II LOADING FORCEPS| PROVISC OPHTHALMIC VISCOSURGICAL DEVICE| VISCOAT OPHTHALMIC VISCOSURGICAL DEVICE |