FDA Adverse Event
Malfunction
Summary report: N
CLAREON TORIC ASPHERIC HYDROPHOBIC ACRYLIC IOL WITH AUTONOME DELIVERY SYSTEM
MDR report key: 23692916
·
Received December 2, 2025
Report
- Report Number
- 9612169-2025-02403
- Event Type
- Malfunction
- Date Received
- December 2, 2025
- Report Date
- December 2, 2025
- Manufacturer
- ALCON LABORATORIES IRELAND LTD.
- Product Code
- MJP
- UDI-DI
- 00380652398091
- PMA / PMN Number
- P190018
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
THE 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 (CNA0T3-T9) 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 CONSUMER REPORTED LOADING ISSUES. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1958285 | CLAREON TORIC ASPHERIC HYDROPHOBIC ACRYLIC IOL WITH AUTONOME DELIVERY SYSTEM | LENS, INTRAOCULAR, TORIC OPTICS | MJP | ALCON LABORATORIES IRELAND LTD. | CNA0T2 | 25818251 | 00380652398091 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |