CLAREON ASPHERIC HYDROPHOBIC ACRYLIC IOL
Report
- Report Number
- 1119421-2025-00753
- Event Type
- Injury
- Date Received
- March 19, 2025
- Date of Event
- November 19, 2024
- Report Date
- January 30, 2026
- Manufacturer
- ALCON RESEARCH, LLC - HUNTINGTON
- Product Code
- HQL
- UDI-DI
- 00380652251471
- PMA / PMN Number
- P190018
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- 003
Narratives
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 PROVIDED IN B.5., D.10., H.3. AND H.6. 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 PROVIDED IN B.5., D6A., E.4. AND H.3. 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 FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT COULDN'T TOLERATE LENS. ADDITIONAL INFORMATION HAS BEEN RECEIVED THAT LENS WAS EXCHANGED FOR COMPANY LENS MODEL AFTER 2 MONTHS. THE PATIENT WAS NOT ABLE TO READ DUE TO EDEMA AFTER LENS EXCHANGE.
ADDITIONAL INFORMATION HAS BEEN RECEIVED THAT PATIENT HAD CORNEAL TRANSPLANT ON (B)(6) 2025, CORNEA WAS CLEAR. VISION WAS NOT IMPROVED SEEN MULTIPLE SPECIALIST AND THEY HAVE NOT DETERMINED CAUSE OF DECREASED VISION.
ADDITIONAL INFORMATION HAS BEEN RECEIVED THAT PATIENT WAS SCHEDULED FOR CORNEAL TRANSPLANT IN EYE DUE CORNEAL ISSUES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 640409 | CLAREON ASPHERIC HYDROPHOBIC ACRYLIC IOL | INTRAOCULAR LENS | HQL | ALCON RESEARCH, LLC - HUNTINGTON | SY60WF | 15893027 | 00380652251471 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR | Male | Required Intervention| O | CLAREON MONARCH IV INJECTOR| CLAREON PANOPTIX TRIFOCAL HYDROPHOBIC| MONARCH III IOL CARTRIDGE D| PROVISC |