FDA Adverse Event
Other
Summary report: N
ACRYSOF TORIC
MDR report key: 1353572
·
Received March 19, 2009
Report
- Report Number
- 1119421-2009-00229
- Event Type
- Other
- Date Received
- March 19, 2009
- Date of Event
- February 1, 2009
- Report Date
- February 17, 2009
- Manufacturer
- ALCON MANUFACTURING, LTD./HUNTINGTON
- Product Code
- MJP
- PMA / PMN Number
- P930014
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE PRODUCT WAS NOT RETURNED FOR ANALYSIS; THE DEVICE REMAINS IMPLANTED. RESULTS FROM THE PRODUCT HISTORY RECORD REVIEW INDICATED THE PRODUCT MET RELEASE CRITERIA. THERE HAVE BEEN NO OTHER COMPLAINTS IN THE LOT NUMBER. ADDITIONAL INFORMATION WAS REQUESTED ON 02/20/2009, 03/03/2009, 03/05/2009, AND 03/06/2009 BY PHONE, FAX, AND MAIL. A COMPLETED QUESTIONNAIRE HAS NOT BEEN RECEIVED. THIS REPORT WAS MAILED TO FDA ON: 03/19/2009.
Description of Event or Problem · 1
A SURGEON REPORTED A PATIENT EXPERIENCING AN UNEXPECTED POSTOPERATIVE REFRACTION FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACRYSOF TORIC | INTRAOCULAR LENS | MJP | ALCON MANUFACTURING, LTD./HUNTINGTON | SN60T5 | 10810763 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 64 YR | Other |