FDA Adverse Event
Other
Summary report: N
ACRYSOF TORIC
MDR report key: 1290895
·
Received December 5, 2008
Report
- Report Number
- 1119421-2008-00992
- Event Type
- Other
- Date Received
- December 5, 2008
- Date of Event
- October 14, 2008
- Report Date
- November 7, 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
- OK, 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 ON 11/10/2008, 11/13/2008, AND 11/24/2008 BY PHONE, FAX AND MAIL. A COMPLETED QUESTIONNAIRE WAS RECEIVED ON 12/03/2008. THIS REPORT WAS MAILED TO FDA ON: 12/05/2008.
Description of Event or Problem · 1
A TECHNICIAN REPORTED A PATIENT WITH AN UNEXPECTED POSTOPERATIVE REFRACTION FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY. THE SURGEON REPORTED THAT THE ASTIGMATISM IS WORSENING WITH A BCVA OF ONLY 20/50. POSTERIOR CAPSULE OPACIFICATION (PCO) WAS NOTED ONE MONTH POSTOPERATIVELY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACRYSOF TORIC | INTRAOCULAR LENS | MJP | ALCON RESEARCH, LTD. / HUNTINGTON | SN60T3 | 10814554 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 72 YR | Other | OCULAR| PREDFORTE |