FDA Adverse Event
Other
Summary report: N
ACRYSOF RESTOR
MDR report key: 932729
·
Received October 24, 2007
Report
- Report Number
- 1119421-2007-00429
- Event Type
- Other
- Date Received
- October 24, 2007
- Date of Event
- January 1, 2007
- Report Date
- September 24, 2007
- Manufacturer
- ALCON LABORATORIES, INC. / HUNTINGTON
- Product Code
- HQL
- PMA / PMN Number
- P040020
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, 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. ADDITIONAL INFORMATION WAS REQUESTED 09/25/2007, 09/27/2007, AND 10/16/2007 BY PHONE, MAIL AND FAX. ADDITIONAL INFORMATION WAS RECEIVED 09/25/2007 BY PHONE. A COMPLETED QUESTIONNAIRE HAS NOT BEEN RETURNED.
Description of Event or Problem · 1
A SURGEON REPORTS A PATIENT WITH AN UNEXPECTED POSTOPERATIVE REFRACTION FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY. ADDITIONAL INFORMATION, INCLUDING PATIENT STATUS, HAS BEEN REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACRYSOF RESTOR | INTRAOCULAR LENS | HQL | ALCON LABORATORIES, INC. / HUNTINGTON | SN6AD3 | 10709186 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NI YR | Other |