FDA Adverse Event
Injury
Summary report: N
CLAREON VIVITY TORIC EXTENDED VISION UV ABSORBING IOL
MDR report key: 17757086
·
Received September 15, 2023
Report
- Report Number
- 9612169-2023-00649
- Event Type
- Injury
- Date Received
- September 15, 2023
- Report Date
- September 15, 2023
- Manufacturer
- ALCON LABORATORIES IRELAND LTD.
- Product Code
- MJP
- UDI-DI
- 00380652455213
- PMA / PMN Number
- P190018
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AL, 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 NON HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED DECREASED VISUAL ACUITY AT DISTANCE. THE PATIENT WAS UNABLE TO PERFORM DAILY TASK. CLINICAL REASON FOR EXPLANT WAS MENTIONED AS IOL ROTATION AND ORIENTATION OF ASTIGMATISM CORRECTION WAS NOT CORRECT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 290367 | CLAREON VIVITY TORIC EXTENDED VISION UV ABSORBING IOL | LENS, INTRAOCULAR, TORIC OPTICS | MJP | ALCON LABORATORIES IRELAND LTD. | CCWET3 | 25352499 | 00380652455213 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Male | Other |