FDA Adverse Event
Injury
Summary report: N
ACRYSOF IQ VIVITY TORIC EXTENDED VISION UV ABSORBING IOL
MDR report key: 15697863
·
Received October 31, 2022
Report
- Report Number
- 1119421-2022-02312
- Event Type
- Injury
- Date Received
- October 31, 2022
- Report Date
- October 31, 2022
- Manufacturer
- ALCON RESEARCH, LLC - HUNTINGTON
- Product Code
- POE
- UDI-DI
- 00380652427111
- PMA / PMN Number
- P930014
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, 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. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).
Description of Event or Problem · 0
A NON HEALTH CARE PROFESSIONAL REPORTED FOLLOWING THE INTRAOCULAR LENS IMPLANTATION THE PATIENT WAS NOT ABLE TO SEE WELL ENOUGH TO DRIVE AND PASS THE CDL. THE LENS WAS EXPLANTED IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR THE EXPLANT WAS MORE MYOPIC THAN EXPECTED- REFRACTIVE SURPRISE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2912492 | ACRYSOF IQ VIVITY TORIC EXTENDED VISION UV ABSORBING IOL | INTRAOCULAR LENS | POE | ALCON RESEARCH, LLC - HUNTINGTON | DAT315 | 15080054 | 00380652427111 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Other| R |