FDA Adverse Event
Other
Summary report: N
ACRYSOF RESTOR
MDR report key: 1448927
·
Received August 20, 2009
Report
- Report Number
- 1119421-2009-00806
- Event Type
- Other
- Date Received
- August 20, 2009
- Date of Event
- June 1, 2009
- Report Date
- July 21, 2009
- Manufacturer
- ALCON RESEARCH, LTD./HUNTINGTON
- Product Code
- MFK
- PMA / PMN Number
- P040020
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SD, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE PRODUCT WAS NOT RETURNED FOR ANALYSIS; DEVICE REMAINS IMPLANTED. 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. ADD'L INFO WAS REQUESTED ON 07/22/2009, 07/27/2009, 07/31/2009, 08/06/2009, AND 08/13/2009 BY PHONE, FAX, AND MAIL. A COMPLETED QUESTIONAIRE HAS NOT BEEN RECEIVED. THIS REPORT WAS MAILED TO FDA ON: 08/20/2009.
Description of Event or Problem · 1
A SURGEON REPORTED THAT FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY, A PT WAS UNHAPPY WITH HER RESULTS. ADD'L INFO HAS BEEN REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACRYSOF RESTOR | INTRAOCULAR LENS | MFK | ALCON RESEARCH, LTD./HUNTINGTON | NI | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |