FDA Adverse Event
Malfunction
Summary report: N
CLAREON PANOPTIX TORIC TRIFOCAL HYDROPHOBIC IOL
MDR report key: 20865318
·
Received December 6, 2024
Report
- Report Number
- 9612169-2024-01264
- Event Type
- Malfunction
- Date Received
- December 6, 2024
- Date of Event
- November 4, 2024
- Report Date
- December 6, 2024
- Manufacturer
- ALCON LABORATORIES IRELAND LTD.
- Product Code
- MJP
- UDI-DI
- 00380652467988
- PMA / PMN Number
- P190018
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- 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. THIS PRODUCT IS NOT APPROVED OR INTRODUCED INTO COMMERCIAL DISTRIBUTION IN THE UNITED STATES. HOWEVER, THIS MEDWATCH IS BEING FILED BASED ON A SIMILAR PRODUCT CNWTT3-T6 THAT IS SOLD IN THE UNITED STATES UNDER (PMA/510(K) (P190018). THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).
Description of Event or Problem · 0
A NON HEALTHCARE PROFESSIONAL REPORTED WITH A DESCRIPTION OF DAMAGED INTRAOCULAR LENS (IOL). ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2093753 | CLAREON PANOPTIX TORIC TRIFOCAL HYDROPHOBIC IOL | LENS, INTRAOCULAR, TORIC OPTICS | MJP | ALCON LABORATORIES IRELAND LTD. | CNWTT2 | 25387904 | 00380652467988 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |