FDA Adverse Event
Injury
Summary report: N
CLAREON VIVITY TORIC EXTENDED VISION UV ABSORBING IOL
MDR report key: 24911451
·
Received April 17, 2026
Report
- Report Number
- 9612169-2026-00880
- Event Type
- Injury
- Date Received
- April 17, 2026
- Report Date
- April 17, 2026
- Manufacturer
- ALCON LABORATORIES IRELAND LTD.
- Product Code
- MJP
- UDI-DI
- 00380652455879
- PMA / PMN Number
- P190018
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, 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 HEALTH CARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED BLURRY VISION AND GLARE. CLINICAL REASON BEING MENTIONED AS IOL COMPLICATION. THE IOL WAS EXPLANTED AND EXCHANGED WITH A NON COMPANY LENS IN THE SECONDARY IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 973692 | CLAREON VIVITY TORIC EXTENDED VISION UV ABSORBING IOL | LENS, INTRAOCULAR, TORIC OPTICS | MJP | ALCON LABORATORIES IRELAND LTD. | CCWET5 | 25318856 | 00380652455879 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention |