FDA Adverse Event
Malfunction
Summary report: N
CLAREON VIVITY TORIC EXTENDED VISION UV ABSORBING IOL
MDR report key: 21047573
·
Received December 31, 2024
Report
- Report Number
- 1119421-2024-02675
- Event Type
- Malfunction
- Date Received
- December 31, 2024
- Report Date
- December 31, 2024
- Manufacturer
- ALCON RESEARCH, LLC - HUNTINGTON
- Product Code
- MJP
- UDI-DI
- 00380652454988
- PMA / PMN Number
- P190018
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
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 (CNWET3-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 HEALTH CARE PROFESSIONAL REPORTED WITH THE DESCRIPTION, THE LENS WAS DAMAGED. THERE WAS PATIENT CONTACT AND SURGERY PROCEEDED WITH BACK UP LENS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1253474 | CLAREON VIVITY TORIC EXTENDED VISION UV ABSORBING IOL | LENS, INTRAOCULAR, TORIC OPTICS | MJP | ALCON RESEARCH, LLC - HUNTINGTON | CCWET2 | 15691282 | 00380652454988 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | DUOVISC VISCOELASTIC SYSTEM| MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D |