FDA Adverse Event
Other
Summary report: N
ACRYSOF TORIC
MDR report key: 1172753
·
Received September 18, 2008
Report
- Report Number
- 1119421-2008-00725
- Event Type
- Other
- Date Received
- September 18, 2008
- Date of Event
- August 1, 2008
- Report Date
- August 19, 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
- IL, 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 INFO WAS REQUESTED ON 08/21/2008, 08/25/2008 AND 09/03/2008 BY PHONE, FAX, AND MAIL. A COMPLETED QUESTIONNAIRE WAS RECEIVED ON 09/10/2008.
Description of Event or Problem · 1
AN OFFICE MANAGER REPORTS A PATIENT WITH AN UNEXPECTED POSTOPERATIVE REFRACTION FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACRYSOF TORIC | INTRAOCULAR LENS | MJP | ALCON RESEARCH, LTD/ HUNTINGTON | SN60T5 | 10810732 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR | Other |