FDA Adverse Event
Injury
Summary report: N
CLAREON PANOPTIX PRO TRIFOCAL UV ABSORBING IOL W/AUTONOME DELIVERY SYSTEM
MDR report key: 22940257
·
Received September 2, 2025
Report
- Report Number
- 9612169-2025-01756
- Event Type
- Injury
- Date Received
- September 2, 2025
- Report Date
- September 2, 2025
- Manufacturer
- ALCON LABORATORIES IRELAND LTD.
- Product Code
- HQL
- UDI-DI
- 00380658490362
- PMA / PMN Number
- P190018
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, 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-HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED POOR DISTANCE VISION. CLINICAL REASON FOR EXPLANT WAS HYPEROPIC REFRACTIVE SURPRISE. THE IOL WAS EXCHANGED FOR ADVANCED TECHNOLOGY INTRAOCULAR LENSES (ATIOL) 28 DAYS FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2075711 | CLAREON PANOPTIX PRO TRIFOCAL UV ABSORBING IOL W/AUTONOME DELIVERY SYSTEM | INTRAOCULAR LENS | HQL | ALCON LABORATORIES IRELAND LTD. | PXCAT0 | 25993339 | 00380658490362 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention |