FDA Adverse Event
Other
Summary report: N
ACRYSOF TORIC
MDR report key: 1172741
·
Received September 17, 2008
Report
- Report Number
- 1119421-2008-00713
- Event Type
- Other
- Date Received
- September 17, 2008
- Date of Event
- August 1, 2008
- Report Date
- August 18, 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
- OH, 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 08/18/2008, 08/19/2008 AND 08/29/2008 BY PHONE, FAX AND MAIL. PATIENT RECORDS WERE RECEIVED 08/18/2008. A COMPLETED QUESTIONNAIRE HAS NOT BEEN RECEIVED.
Description of Event or Problem · 1
A SURGEON REPORTS HAVING A PATIENT WITH AN UNEXPECTED POSTOPERATIVE REFRACTION AND ASTIGMATISM AFTER 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 RESEARCH, LTD./ HUNTINGTON | SN60T3 | 10808321 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 83 YR | Other |