CLAREON ASPHERIC HYDROPHOBIC ACRYLIC IOL
Report
- Report Number
- 1119421-2025-02545
- Event Type
- Malfunction
- Date Received
- September 22, 2025
- Date of Event
- April 17, 2025
- Report Date
- October 14, 2025
- Manufacturer
- ALCON RESEARCH, LLC - HUNTINGTON
- Product Code
- HQL
- PMA / PMN Number
- P190018
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- 003
Narratives
ADDITIONAL INFORMATION HAS BEEN PROVIDED IN B.2., B.3., B.5., D.10., H.3., H.6., AND H.11. 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.
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). H.10 REFLECTS ALL RELATED REPORT NUMBERS ASSOCIATED WITH THIS PRODUCT EVENT THAT HAVE BEEN SUBMITTED AT THIS TIME.
ADDITIONAL INFORMATION WAS RECEIVED BY STATING, LENS WAS CAUGHT IN CARTRIDGE. THERE WAS NO PATIENT CONTACT AND HARM.
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS WAS JAMMED INTO INJECTOR. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2595380 | CLAREON ASPHERIC HYDROPHOBIC ACRYLIC IOL | INTRAOCULAR LENS | HQL | ALCON RESEARCH, LLC - HUNTINGTON | SY60WF | 15921793 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | DUOVISC VISCOELASTIC SYSTEM| MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D| UNSPECIFIED INJECTOR |