FDA Adverse Event
Injury
Summary report: N
CLAREON PANOPTIX TORIC TRIFOCAL UV ABSORBING IOL
MDR report key: 23356034
·
Received October 22, 2025
Report
- Report Number
- 1119421-2025-02735
- Event Type
- Injury
- Date Received
- October 22, 2025
- Report Date
- October 22, 2025
- Manufacturer
- ALCON RESEARCH, LLC - HUNTINGTON
- Product Code
- MJP
- UDI-DI
- 00380652457460
- PMA / PMN Number
- P190018
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, 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 AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT REASON AS IOL CAME TOO STRONG AND CLINICAL REASON FOR EXPLANT BEING BLURRY VISION IOL CAME TOO STRONG. THE IOL WAS EXPLANTED AND EXCHANGED FOR AN UNKNOWN ADVANCED TECHNOLOGY INTRAOCULAR LENS FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 242888 | CLAREON PANOPTIX TORIC TRIFOCAL UV ABSORBING IOL | LENS, INTRAOCULAR, TORIC OPTICS | MJP | ALCON RESEARCH, LLC - HUNTINGTON | CCWTT3 | 15328830 | 00380652457460 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention |