FDA Adverse Event
Injury
Summary report: N
CLAREON VIVITY EXTENDED VISION UV ABSORBING IOL
MDR report key: 22565026
·
Received July 22, 2025
Report
- Report Number
- 1119421-2025-02003
- Event Type
- Injury
- Date Received
- July 22, 2025
- Report Date
- July 22, 2025
- Manufacturer
- ALCON RESEARCH, LLC - HUNTINGTON
- Product Code
- POE
- UDI-DI
- 00380652405836
- PMA / PMN Number
- P190018
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, 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 DECREASED VISION. CLINICAL REASON BEING MENTIONED AS EXCHANGE FOR SAME LENS, DIFFERENT POWER AND REFRACTIVE SURPRISE. THE IOL WAS EXPLANTED AND EXCHANGED WITH AN UNKNOWN ATIOL (ADVANCED TECHNOLOGY INTRAOCULAR LENS) IN THE SECONDARY IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 778745 | CLAREON VIVITY EXTENDED VISION UV ABSORBING IOL | EXTENDED DEPTH OF FOCUS INTRAOCULAR LENS | POE | ALCON RESEARCH, LLC - HUNTINGTON | CCWET0 | 15863705 | 00380652405836 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention |