FDA Adverse Event
Injury
Summary report: N
CLAREON VIVITY TORIC EXTENDED VISION UV ABSORBING IOL
MDR report key: 23412223
·
Received October 29, 2025
Report
- Report Number
- 1119421-2025-02814
- Event Type
- Injury
- Date Received
- October 29, 2025
- Report Date
- October 29, 2025
- Manufacturer
- ALCON RESEARCH, LLC - HUNTINGTON
- Product Code
- MJP
- UDI-DI
- 00380652455312
- PMA / PMN Number
- P190018
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
A SAMPLE DEVICE 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, THE PATIENT VISION WAS NOT CLEAR IN ANY FIELD. THE IOL WAS EXCHANGED FOR UNSPECIFIED ADVANCED TECHNOLOGY INTRAOCULAR LENS. CLINICAL REASON FOR EXPLANT MENTIONED AS UNDER CORRECTED ASTIGMATISM/WRONG IOL SELECTION. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 219153 | CLAREON VIVITY TORIC EXTENDED VISION UV ABSORBING IOL | LENS, INTRAOCULAR, TORIC OPTICS | MJP | ALCON RESEARCH, LLC - HUNTINGTON | CCWET3 | 15989795 | 00380652455312 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention |