FDA Adverse Event
Other
Summary report: N
ACRYSOF RESTOR
MDR report key: 863697
·
Received June 6, 2007
Report
- Report Number
- 1119421-2007-00234
- Event Type
- Other
- Date Received
- June 6, 2007
- Date of Event
- January 1, 2007
- Report Date
- May 7, 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
- CT, 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 THIS LOT NUMBER. ADDITIONAL INFORMATION WAS REQUESTED 05/08/2007, 05/11/2007, 05/14/2007 AND 05/24/2007 BY PHONE, MAIL AND FAX. ADDITIONAL INFORMATION WAS RECEIVED 05/08/2007 AND 05/14/2007 BY PHONE. A COMPLETED QUESTIONNAIRE HAS NOT BEEN RETURNED.
Description of Event or Problem · 1
A SURGEON REPORTED THAT FOLLOWING BILATERAL INTRAOCULAR LENS (IOL) IMPLANT SURGERY, A PT REPORTS BLURRY VISION, BOTH NEAR AND DISTANT. ADD'L INFO, INCLUDING PT STATUS, HAS BEEN REQUESTED. RIGHT EYE: MDR #1119421-2007-00234. LEFT EYE: MDR #1119421-2007-00235.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACRYSOF RESTOR | INTRAOCULAR LENS | HQL | ALCON LABORATORIES, INC. / HUNTINGTON | SN60D3 | 943293 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 54 YR | Other |