FDA Adverse Event
Injury
Summary report: N
CLAREON VIVITY EXTENDED VISION HYDROPHOBIC IOL
MDR report key: 21374023
·
Received February 13, 2025
Report
- Report Number
- 9612169-2025-00202
- Event Type
- Injury
- Date Received
- February 13, 2025
- Report Date
- February 13, 2025
- Manufacturer
- ALCON LABORATORIES IRELAND LTD.
- Product Code
- POE
- UDI-DI
- 00380652405300
- PMA / PMN Number
- P190018
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, 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 INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, PATIENT EXPERIENCED BLURRED VISION. THE LENS WAS EXCHANGED FOR AN UNKNOWN ADVANCED TECHNOLOGY INTRAOCULAR LENS (ATIOL) AFTER THE INITIAL IMPLANT PROCEDURE. CLINICAL REASON WAS UNEXPLAINED POOR OUTCOME. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 881104 | CLAREON VIVITY EXTENDED VISION HYDROPHOBIC IOL | EXTENDED DEPTH OF FOCUS INTRAOCULAR LENS | POE | ALCON LABORATORIES IRELAND LTD. | CNWET0 | 25325677 | 00380652405300 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention |