FDA Adverse Event
Injury
Summary report: N
ACRYSOF IQ VIVITY TORIC EXTENDED VISION UV ABSORBING IOL
MDR report key: 22403305
·
Received July 4, 2025
Report
- Report Number
- 1119421-2025-01836
- Event Type
- Injury
- Date Received
- July 4, 2025
- Report Date
- July 4, 2025
- Manufacturer
- ALCON RESEARCH, LLC - HUNTINGTON
- Product Code
- POE
- UDI-DI
- 00380652427821
- PMA / PMN Number
- P930014
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KY, 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, THE PATIENT HAD BLURRY VISION. THE IOL WAS EXCHANGED FOR ADVANCED TECHNOLOGY INTRAOCULAR LENSES. CLINICAL REASON FOR EXPLANT MENTIONED AS ROTATION OF IOL AND RESIDUAL MYOPIA. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2757046 | ACRYSOF IQ VIVITY TORIC EXTENDED VISION UV ABSORBING IOL | INTRAOCULAR LENS | POE | ALCON RESEARCH, LLC - HUNTINGTON | DAT415 | 15085713 | 00380652427821 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention |