FDA Adverse Event
Other
Summary report: N
ACRYSOF RESTOR
MDR report key: 870341
·
Received June 22, 2007
Report
- Report Number
- 1119421-2007-00269
- Event Type
- Other
- Date Received
- June 22, 2007
- Date of Event
- January 1, 2007
- Report Date
- May 24, 2007
- Manufacturer
- ALCON LABORATORIES, INC. / HUNTINGTON
- Product Code
- HQL
- PMA / PMN Number
- P040020
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, 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 THIS LOT NUMBER. ADD'L INFO WAS REQUESTED 05/24/2007, 05/25/2007 AND 05/29/2007 BY PHONE, MAIL AND FAX. ADD'L INFO RECEIVED 05/24/2007, 05/25/2007 AND 06/05/2007 BY PHONE AND FAX.
Description of Event or Problem · 1
A SURGEON REPORTS THAT FOLLOWING BILATERAL INTRAOCULAR LENS (IOL) SURGERY, A PT REPORTED BLURRY VISION. RIGHT EYE: MDR #1119421-2007-00269, LEFT EYE: MDR #1119421-2007-00270.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACRYSOF RESTOR | INTRAOCULAR LENS | HQL | ALCON LABORATORIES, INC. / HUNTINGTON | SN60D3 | 983301 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 78 YR | Other |