FDA Adverse Event
Other
Summary report: N
ACRYSOF RESTOR
MDR report key: 1353613
·
Received March 26, 2009
Report
- Report Number
- 1119421-2009-00277
- Event Type
- Other
- Date Received
- March 26, 2009
- Date of Event
- February 1, 2009
- Report Date
- February 24, 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
- NJ, 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 # OR ANY IDENTIFICATION TRACEABLE TO THE MFG DOCUMENTATION. ADDITIONAL INFO WAS REQUESTED ON 02/26/2009, 03/12/2009 ADM 03/19/2009 BY PHONE, FAX AND MAIL. A COMPLETED QUESTIONAIRE HAS NOT BEEN RECEIVED. THIS REPORT WAS MAILED TO FDA ON: 03/26/2009.
Description of Event or Problem · 1
A SURGEON REPORTED AN UNEXPECTED POSTOPERATIVE REFRACTION FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY. ADDITIONAL 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 | SN6AD3 | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 57 YR | Other |