FDA Adverse Event
Injury
Summary report: N
CLAREON VIVITY TORIC EXTENDED VISION UV ABSORBING IOL
MDR report key: 22780758
·
Received August 12, 2025
Report
- Report Number
- 1119421-2025-02237
- Event Type
- Injury
- Date Received
- August 12, 2025
- Report Date
- August 12, 2025
- Manufacturer
- ALCON RESEARCH, LLC - HUNTINGTON
- Product Code
- MJP
- UDI-DI
- 00380652455183
- PMA / PMN Number
- P190018
- Removal / Correction Number
- NA
- Adverse Event
- 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-HEALTH CARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED BLURRY VISION AND WAS NOT HAPPY WITH OUTCOME. THE IOL WAS EXCHANGED FOR ADVANCED TECHNOLOGY INTRAOCULAR LENS. CLINICAL REASON FOR EXPLANT MENTIONED AS HYPEROPIC. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2364021 | CLAREON VIVITY TORIC EXTENDED VISION UV ABSORBING IOL | LENS, INTRAOCULAR, TORIC OPTICS | MJP | ALCON RESEARCH, LLC - HUNTINGTON | CCWET3 | 15718156 | 00380652455183 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention |