FDA Adverse Event
Injury
Summary report: N
CLAREON VIVITY EXTENDED VISION UV ABSORBING IOL
MDR report key: 22538903
·
Received July 17, 2025
Report
- Report Number
- 1119421-2025-01964
- Event Type
- Injury
- Date Received
- July 17, 2025
- Report Date
- July 17, 2025
- Manufacturer
- ALCON RESEARCH, LLC - HUNTINGTON
- Product Code
- POE
- UDI-DI
- 00380652405775
- PMA / PMN Number
- P190018
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, 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 FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, PATIENT HAD BLURRED VISION AND RESIDUAL REFRACTIVE ERROR. THE LENS WAS EXCHANGED FOR AN UNKNOWN ADVANCED TECHNOLOGY INTRAOCULAR LENS (ATIOL) AFTER THE INITIAL IMPLANT PROCEDURE. CLINICAL REASON FOR EXPLANT WAS RESIDUAL REFRACTIVE ERROR AND MECHANICAL COMPLICATIONS OF IOL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 821432 | CLAREON VIVITY EXTENDED VISION UV ABSORBING IOL | EXTENDED DEPTH OF FOCUS INTRAOCULAR LENS | POE | ALCON RESEARCH, LLC - HUNTINGTON | CCWET0 | 15795982 | 00380652405775 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention |