FDA Adverse Event
Malfunction
Summary report: N
ACRYSOF IQ SINGLEPIECE IOL WITH ULTRASERT DELIVERY SYSTEM
MDR report key: 20514509
·
Received October 23, 2024
Report
- Report Number
- 1119421-2024-02055
- Event Type
- Malfunction
- Date Received
- October 23, 2024
- Date of Event
- September 1, 2024
- Report Date
- January 10, 2025
- Manufacturer
- ALCON RESEARCH, LLC - HUNTINGTON
- Product Code
- KYB
- UDI-DI
- 00380652394819
- PMA / PMN Number
- P930014
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SI
- 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. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).
Additional Manufacturer Narrative · 0
CORRECTION: ON INITIAL MDR THE PRODUCT CODE OF A150204 WAS INCORRECT. IT SHOULD HAVE BEEN A050301 ON THE ORIGINAL MDR. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).
Description of Event or Problem · 0
A FACILITY REPRESENTATIVE REPORTED WITH A DESCRIPTION OF PLUNGER WENT OVER THE LENS WHEN FOLDING IT, DAMAGING IT IN THE PROCESS. THE PROCEDURE WAS COMPLETED WITH ANOTHER LENS. ADDITIONAL INFORMATION WAS REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 361679 | ACRYSOF IQ SINGLEPIECE IOL WITH ULTRASERT DELIVERY SYSTEM | LENS, GUIDE, INTRAOCULAR | KYB | ALCON RESEARCH, LLC - HUNTINGTON | AU00T0 | 15786481 | 00380652394819 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | PROVISC. |