FDA Adverse Event
Other
Summary report: N
ACRYSOF RESTOR
MDR report key: 883055
·
Received July 19, 2007
Report
- Report Number
- 1119421-2007-00300
- Event Type
- Other
- Date Received
- July 19, 2007
- Date of Event
- January 1, 2007
- Report Date
- June 19, 2007
- Manufacturer
- ALCON LABORATORIES, INC.
- Product Code
- HQL
- PMA / PMN Number
- P040020
- 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; THE DEVICE REMAINS IMPLANTED. 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 06/20/2007 AND 06/28/2007 BY MAIL, PHONE AND FAX. ADDITIONAL INFORMATION WAS RECEIVED 06/20/2007 AND 07/02/2007 BY PHONE AND FAX.
Description of Event or Problem · 1
A SURGEON REPORTS, THAT FOLLOWING BILATERAL INTRAOCULAR LENS (IOL) IMPLANT SURGERY, A PATIENT REPORTS SEEING SPARKLES AT NIGHT THAT INTERFERE WITH DRIVING AND GLARE DURING THE DAY WHEN SUNLIGHT REFLECTS OFF OF AUTOMOBILES. LEFT EYE: MDR #1119421-2007-00300. RIGHT EYE: MDR #1119421-2007-00301.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACRYSOF RESTOR | INTRAOCULAR LENS | HQL | ALCON LABORATORIES, INC. | SA60D3 | 894648 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 85 YR | Other |