FDA Adverse Event
Injury
Summary report: N
CLAREON PANOPTIX TRIFOCAL HYDROPHOBIC INTRAOCULAR LENS
MDR report key: 20805835
·
Received November 28, 2024
Report
- Report Number
- 1119421-2024-02338
- Event Type
- Injury
- Date Received
- November 28, 2024
- Report Date
- December 26, 2024
- 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
- NY, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
CORRECTED INFORMATION PROVIDED IN D4. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).
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 HEALTH CARE PROFESSIONAL REPORTED THAT AFTER SURGERY, THE PATIENT EXPERIENCED REFRACTIVE SURPRISE. THE IOL WAS EXPLANTED AND EXCHANGED FOR AN UNKNOWN ATIOL (ADVANCED TECHNOLOGY INTRAOCULAR LENS) FOLLOWING THE SECONDARY IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2446574 | CLAREON PANOPTIX TRIFOCAL HYDROPHOBIC INTRAOCULAR LENS | LENS, MULTIFOCAL INTRAOCULAR | MFK | ALCON RESEARCH, LLC - HUNTINGTON | CNWTT0 | 15261327 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention |