FDA Adverse Event
Other
Summary report: N
ACRYSOF RESTOR
MDR report key: 846878
·
Received May 9, 2007
Report
- Report Number
- 1119421-2007-00176
- Event Type
- Other
- Date Received
- May 9, 2007
- Date of Event
- January 1, 2007
- Report Date
- April 9, 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
- NY, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. PRODUCT HISTORY RECORDS COULD NOT BE REVIEWED BECAUSE THE REPORTING FACILITY DID NOT PROVIDE A LOT NUMBER OR ANY IDENTIFICATION TRACEABLE TO THE MFG DOCUMENTATION. THIS REPORT WAS MAILED TO THE FDA ON: 05/09/2007. ADDITIONAL INFO WAS REQUESTED ON 04/10/2007, 04/12/2007 AND 04/26/2007 BY EMAIL, MAIL, PHONE, AND FAX. ADDITIONAL INFORMATION WAS PROVIDED BY EMAIL 04/10/2007. A COMPLETED QUESTIONNAIRE HAS NOT BEEN RETURNED.
Description of Event or Problem · 1
A SURGEON REPORTS THAT FOLLOWING BILATERAL INTRAOCULAR LENS (IOL) IMPLANT SURGERY, A PT REPORTED NIGHT GLARE AND HALOS IN ADDITION TO MARGINAL NEAR VISION. SECOND EYE: MDR # 1119421-2007-00177.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACRYSOF RESTOR | INTRAOCULAR LENS | HQL | ALCON LABORATORIES INC./HUNTINGTON | UNK | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 64 YR | Other |