FDA Adverse Event
Injury
Summary report: N
ACRYSOF
MDR report key: 1002280
·
Received February 22, 2008
Report
- Report Number
- 1119421-2008-00085
- Event Type
- Injury
- Date Received
- February 22, 2008
- Date of Event
- December 7, 2007
- Report Date
- January 23, 2008
- Manufacturer
- ALCON RESEARCH, LTD. / HUNTINGTON
- Product Code
- HQL
- PMA / PMN Number
- P930014
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- UNKNOWN
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 ARE NO OTHER REPORTS IN THE LOT. ADD'L INFO WAS REQUESTED. ADD'L INFO WAS RECEIVED ON 02/04/2008 AND 02/06/2008.
Description of Event or Problem · 1
A SURGEON REPORTS, THAT DURING INTRAOCULAR LENS (IOL) IMPLANT SURGERY, HE NOTICED ONE HAPTIC HAD DETACHED FROM THE OPTIC. THE LENS WAS CUT INTO TWO PIECES AND REMOVED. DURING THE PROCESS, A CAPSULAR TEAR OCCURRED. A NEW LENS WAS IMPLANTED WITHOUT DIFFICULTY DURING THE SAME PROCEDURE. THE SURGEON REPORTS THAT THE PT IS DOING WELL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACRYSOF | INTRAOCULAR LENS | HQL | ALCON RESEARCH, LTD. / HUNTINGTON | MA50BM | 10722821 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK YR | Required Intervention | VISCOELASTIC |