FDA Adverse Event
Malfunction
Summary report: N
ACRYSOF RESTOR
MDR report key: 830476
·
Received October 20, 2006
Report
- Report Number
- 1119421-2006-00357
- Event Type
- Malfunction
- Date Received
- October 20, 2006
- Report Date
- February 22, 2006
- Manufacturer
- ALCON LABORATORIES, INC./HUNTINGTON
- Product Code
- HQL
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE COMPLAINT DEVICE ASSOCIATED WITH THIS REPORT HAS NOT BEEN RECEIVED FOR EVALUATION. THERE HAVE BEEN ON OTHER COMPLAINTS RECEIVED FOR THIS LOT NUMBER. ADDITIONAL INFORMATION HAS BEEN REQUESTED BY MAIL ON 09/25/2006 AND 10/10/2006.
Description of Event or Problem · 1
A USER FACILITY REPORTS A SCRATCH WAS NOTED ON THE INTRAOCULAR LENS WHEN THE PACKAGE WAS OPENED. IT IS NOT KNOWN WHETHER THERE WAS PATIENT IMPACT/INJURY ASSOCIATED WITH THIS REPORT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACRYSOF RESTOR | INTRAOCULAR LENS | HQL | ALCON LABORATORIES, INC./HUNTINGTON | SN60D3 | 922451 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |