FDA Adverse Event
Injury
Summary report: N
CLAREON PANOPTIX TRIFOCAL UV ABSORBING INTRAOCULAR LENS
MDR report key: 23131401
·
Received September 24, 2025
Report
- Report Number
- 1119421-2025-02567
- Event Type
- Injury
- Date Received
- September 24, 2025
- Report Date
- September 24, 2025
- Manufacturer
- ALCON RESEARCH, LLC - HUNTINGTON
- Product Code
- MFK
- PMA / PMN Number
- P190018
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, 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 ACUITY. CLINICAL REASON BEING MENTIONED AS INTOLERABLE VISION RELATED TO MF (MONOFOCAL) LENS DESIGN. THE IOL WAS EXPLANTED AND EXCHANGED FOR 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 |
|---|---|---|---|---|---|---|---|
| 2394590 | CLAREON PANOPTIX TRIFOCAL UV ABSORBING INTRAOCULAR LENS | LENS, MULTIFOCAL INTRAOCULAR | MFK | ALCON RESEARCH, LLC - HUNTINGTON | CCWTT0 | 15618304 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention |