FDA Adverse Event
Other
Summary report: N
ACRYSOF RESTOR
MDR report key: 936564
·
Received November 1, 2007
Report
- Report Number
- 1119421-2007-00442
- Event Type
- Other
- Date Received
- November 1, 2007
- Date of Event
- January 1, 2007
- Report Date
- October 2, 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; THE DEVICE REMAINS IMPLANTED. PRODUCT HISTORY RECORDS COULD NOT BE REVIEWED BECAUSE THE REPORTING FACILITY DID NOT PROVIDE A LOT NUMBER OF ANY IDENTIFICATION TRACEABLE TO THE MANUFACTURING DOCUMENTATION. ADDITIONAL INFORMATION WAS REQUESTED 10/02/2007, 10/08/2007 AND 10/16/2007 BY MAIL AND PHONE. NO INFORMATION HAS BEEN RECEIVED.
Description of Event or Problem · 1
A SURGEONS REPORTS 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 | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NI YR | Other |