FDA Adverse Event
Other
Summary report: N
ACRYSOF RESTOR
MDR report key: 863151
·
Received June 8, 2007
Report
- Report Number
- 1119421-2007-00247
- Event Type
- Other
- Date Received
- June 8, 2007
- Date of Event
- January 1, 2007
- Report Date
- May 9, 2007
- Manufacturer
- ALCON LABS, INC./HUNTINGTON
- Product Code
- HQL
- PMA / PMN Number
- P040020
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, 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 SIMILAR COMPLAINTS REPORTED IN THIS LOT NUMBER. ADD'L INFO WAS REQUESTED 05/13/2007, 05/16/2007, 05/21/2007, 05/25/2007, AND 05/29/2007 BY MAIL, FAX, AND PHONE. A COMPLETED QUESTIONNAIRE HAS NOT BEEN RETURNED.
Description of Event or Problem · 1
A SURGEON REPORTS THAT FOLLOWING BILATERAL INTRAOCULAR LENS (IOL) IMPLANT SURGERY, A PT REPORTED BLURRY VISION NEAR AND DISTANCE. RIGHT EYE MDR#1119421-2007-00246, LEFT EYE MDR# 1119421-2007-00247.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACRYSOF RESTOR | INTRAOCULAR LENS | HQL | ALCON LABS, INC./HUNTINGTON | SN60D3 | 957336 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NI YR | Other |