ACRYSOF IQ VIVITY TORIC EXTENDED VISION IOL
Report
- Report Number
- 1119421-2025-02994
- Event Type
- Malfunction
- Date Received
- November 21, 2025
- Date of Event
- October 1, 2025
- Report Date
- March 17, 2026
- Manufacturer
- ALCON RESEARCH, LLC - HUNTINGTON
- Product Code
- POE
- UDI-DI
- 00380652422826
- PMA / PMN Number
- P930014
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
ADDITIONAL INFORMATION PROVIDED IN B.3., B.5., D.10. AND H.6. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).
A SAMPLE DEVICE 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 (DFT315-615) THAT IS SOLD IN THE UNITED STATES UNDER (PMA/510(K) # (P930014). THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).
ADDITIONAL INFORMATION HAS BEEN REQUESTED, RECEIVED AND STATED THERE WAS AN ISSUE WITH THE SHOOTER AND THE LENS GOT STUCK. A STANDBY IOL WAS USED AND THE SURGERY WAS COMPLETED. THERE WAS NO PATIENT IMPACT.
A HEALTH CARE PROFESSIONAL REPORTED WITH A DESCRIPTION OF DEFECTIVE INTRAOCULAR LENS (IOL). ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2464277 | ACRYSOF IQ VIVITY TORIC EXTENDED VISION IOL | INTRAOCULAR LENS | POE | ALCON RESEARCH, LLC - HUNTINGTON | DFT215 | 15698760 | 00380652422826 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |