FDA Adverse Event
Injury
Summary report: N
CLAREON PANOPTIX TRIFOCAL HYDROPHOBIC INTRAOCULAR LENS
MDR report key: 23776950
·
Received December 11, 2025
Report
- Report Number
- 1119421-2025-03115
- Event Type
- Injury
- Date Received
- December 11, 2025
- Report Date
- December 11, 2025
- Manufacturer
- ALCON RESEARCH, LLC - HUNTINGTON
- Product Code
- MFK
- UDI-DI
- 00380652408202
- PMA / PMN Number
- P190018
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, 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, AFTER INTRAOCULAR LENS IMPLANTATION SURGERY, THE PATIENT EXPERIENCED BLURRED VISION. HENCE THE LENS WAS EXPLANTED AND REPLACED WITH ADVANCED TECHNOLOGY INTRAOCULAR LENS IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR EXPLANT WAS REFRACTIVE ERROR. ADDITIONAL INFORMATION WAS REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2796383 | CLAREON PANOPTIX TRIFOCAL HYDROPHOBIC INTRAOCULAR LENS | LENS, MULTIFOCAL INTRAOCULAR | MFK | ALCON RESEARCH, LLC - HUNTINGTON | CNWTT0 | 15855643 | 00380652408202 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention |