FDA Adverse Event
Injury
Summary report: N
CLAREON VIVITY EXTENDED VISION HYDROPHOBIC IOL
MDR report key: 23348980
·
Received October 21, 2025
Report
- Report Number
- 9612169-2025-02097
- Event Type
- Injury
- Date Received
- October 21, 2025
- Report Date
- October 21, 2025
- Manufacturer
- ALCON LABORATORIES IRELAND LTD.
- Product Code
- POE
- UDI-DI
- 00380652405232
- 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 NON HEALTH CARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED BLURRY DISTANCE VISION. CLINICAL REASON BEING MENTIONED AS UNEXPECTED REFLECTED OUTCOME. THE IOL WAS EXPLANTED AND EXCHANGED WITH AN UNKNOWN ATIOL (ADVANCED TECHNOLOGY INTRAOCULAR LENS) IN THE SECONDARY IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2354805 | CLAREON VIVITY EXTENDED VISION HYDROPHOBIC IOL | EXTENDED DEPTH OF FOCUS INTRAOCULAR LENS | POE | ALCON LABORATORIES IRELAND LTD. | CNWET0 | 25517436 | 00380652405232 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention | PROVISC OPHTHALMIC VISCOSURGICAL DEVICE |