FDA Adverse Event
Malfunction
Summary report: N
ACRYSOF TORIC
MDR report key: 1033484
·
Received April 24, 2008
Report
- Report Number
- 1119421-2008-00266
- Event Type
- Malfunction
- Date Received
- April 24, 2008
- Date of Event
- January 1, 2008
- Report Date
- March 25, 2008
- Manufacturer
- ALCON RESEARCH, LTD.
- Product Code
- HQL
- PMA / PMN Number
- P930014
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- ID, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. RESULTS FROM THE PRODUCT HISTORY RECORD REVIEW INDICATED THE PRODUCT MET RELEASE CRITERIA. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. ADDITIONAL INFO WAS REQUESTED 03/31/2008 BY MAIL. A COMPLETED QUESTIONNAIRE WAS RECEIVED 04/18/2008.
Description of Event or Problem · 1
A USER FACILITY REPORTS A SCRATCH WAS NOTED ON THE OPTIC PRIOR TO INTRAOCULAR LENS (IOL) IMPLANT SURGERY. THERE WAS NO PT IMPACT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACRYSOF TORIC | INTRAOCULAR LENS | HQL | ALCON RESEARCH, LTD. | SN60T5 | 10734252 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |