FDA Adverse Event
Other
Summary report: N
ACRYSOF TORIC
MDR report key: 1083559
·
Received July 25, 2008
Report
- Report Number
- 1119421-2008-00557
- Event Type
- Other
- Date Received
- July 25, 2008
- Date of Event
- January 1, 2008
- Report Date
- June 26, 2008
- Manufacturer
- ALCON RESEARCH , LTD./HUNTINGTON
- Product Code
- MJP
- PMA / PMN Number
- P930014
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, 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 REPORTED IN THE LOT NUMBER. ADDITIONAL INFORMATION WAS REQUESTED 06/26/2008, 06/30/2008, 07/08/2008 AND 07/16/2008 BY PHONE, FAX AND MAIL. ADDITIONAL INFORMATION WAS RECEIVED 07/18/2008 BY PHONE. A COMPLETED QUESTIONNAIRE HAS NOT BEEN RECEIVED.
Description of Event or Problem · 1
A TECHNICIAN REPORTED THAT A SURGEON HAD A PATIENT WITH AN UNEXPECTED POSTOPERATIVE REFRACTION FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY. THE PATIENT WAS INITIALLY -2.5 DIOPTERS AND IS NOW -2 DIOPTERS. THE SURGEON BELIEVES THIS MAY IMPROVE OVER TIME. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACRYSOF TORIC | INTRAOCULAR LENS | MJP | ALCON RESEARCH , LTD./HUNTINGTON | SN60T4 | 10809742 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NI | Other |