CLAREON PANOPTIX TORIC TRIFOCAL HYDROPHOBIC IOL
Report
- Report Number
- 9612169-2026-00356
- Event Type
- Injury
- Date Received
- February 16, 2026
- Date of Event
- December 17, 2025
- Report Date
- February 16, 2026
- Manufacturer
- ALCON LABORATORIES IRELAND LTD.
- Product Code
- MJP
- UDI-DI
- 00380652467964
- PMA / PMN Number
- P190018
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
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 (CCWTT3-T6) THAT IS SOLD IN THE UNITED STATES UNDER (PMA/510(K) # (P190018).¿ THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).
A HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING INTRAOCULAR LENS IMPLANTATION, LENS WERE REPLACED WITH A PRODUCT FROM ANOTHER MANUFACTURER AND IT WAS ALSO STATED THAT IT WAS DIFFICULT TO DETERMINE WHETHER THE CAUSE IS A POWER DIFFERENCE, PATIENT-RELATED FACTOR, OR PRODUCT RELATED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS 2 OF 2. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 405789 | CLAREON PANOPTIX TORIC TRIFOCAL HYDROPHOBIC IOL | LENS, INTRAOCULAR, TORIC OPTICS | MJP | ALCON LABORATORIES IRELAND LTD. | CNWTT2 | 25451539 | 00380652467964 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention |