FDA Adverse Event
Injury
Summary report: N
CLAREON PANOPTIX PRO TRIFOCAL TORIC IOL W/AUTONOME DELIVERY SYSTEM
MDR report key: 23682337
·
Received December 1, 2025
Report
- Report Number
- 9612169-2025-02397
- Event Type
- Injury
- Date Received
- December 1, 2025
- Report Date
- December 1, 2025
- Manufacturer
- ALCON LABORATORIES IRELAND LTD.
- Product Code
- MJP
- UDI-DI
- 00380658494018
- PMA / PMN Number
- P190018
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, 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 POOR NEAR VISION. CLINICAL REASON BEING MENTIONED AS CLOUDY IOL. THE IOL WAS EXPLANTED AND EXCHANGED WITH AN UNSPECIFIED 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 |
|---|---|---|---|---|---|---|---|
| 2080015 | CLAREON PANOPTIX PRO TRIFOCAL TORIC IOL W/AUTONOME DELIVERY SYSTEM | LENS, INTRAOCULAR, TORIC OPTICS | MJP | ALCON LABORATORIES IRELAND LTD. | PXYAT3 | 26042913 | 00380658494018 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention |