FDA Adverse Event
Injury
Summary report: N
ACRYSOF
MDR report key: 1253140
·
Received December 5, 2008
Report
- Report Number
- 1119421-2008-00987
- Event Type
- Injury
- Date Received
- December 5, 2008
- Date of Event
- November 15, 2006
- Report Date
- November 6, 2008
- Manufacturer
- ALCON RESEARCH, LTD. /HUNTINGTON
- Product Code
- HQL
- PMA / PMN Number
- P930014
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, 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 INFORMATION WAS REQUESTED ON 11/07/2008, 11/11/2008, 11/21/2008, AND 11/25/2008 BY PHONE, FAX, AND MAIL. A COMPLETED QUESTIONNAIRE WAS RECEIVED ON 12/01/2008.
Description of Event or Problem · 1
A SURGEON REPORTED THAT ONE WEEK FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT SURGERY, THE PATIENT CHANGED HER MIND AND WANTED ANOTHER MODEL LENS. THE LENS WAS EXCHANGED FOR A DIFFERENT MODEL. THE ORIGINAL SURGERY AND LENS EXCHANGE WERE DONE IN 2006.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACRYSOF | INTRAOCULAR LENS | HQL | ALCON RESEARCH, LTD. /HUNTINGTON | SN60WF | 110048 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR | Required Intervention |