FDA Adverse Event
Injury
Summary report: N
CLAREON PANOPTIX TORIC TRIFOCAL UV ABSORBING IOL
MDR report key: 23244895
·
Received October 8, 2025
Report
- Report Number
- 1119421-2025-02653
- Event Type
- Injury
- Date Received
- October 8, 2025
- Report Date
- October 8, 2025
- Manufacturer
- ALCON RESEARCH, LLC - HUNTINGTON
- Product Code
- MJP
- PMA / PMN Number
- P190018
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UT, 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 VISION. CLINICAL REASON BEING MENTIONED AS MECHANICAL COMPLICATION OF IOL. 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 |
|---|---|---|---|---|---|---|---|
| 2662867 | CLAREON PANOPTIX TORIC TRIFOCAL UV ABSORBING IOL | LENS, INTRAOCULAR, TORIC OPTICS | MJP | ALCON RESEARCH, LLC - HUNTINGTON | CCWTT3 | 15450263 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention |