FDA Adverse Event
Other
Summary report: N
ACRYSOF TORIC
MDR report key: 1211496
·
Received October 23, 2008
Report
- Report Number
- 1119421-2008-00838
- Event Type
- Other
- Date Received
- October 23, 2008
- Date of Event
- July 1, 2008
- Report Date
- September 23, 2008
- Manufacturer
- ALCON RESEARCH, LTD.
- Product Code
- MJP
- PMA / PMN Number
- P930014
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, 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 09/26/2008 AND 10/10/2008 BY PHONE, FAX, AND MAIL. A COMPLETED QUESTIONNAIRE WAS RECEIVED ON 10/15/2008. THIS REPORT WAS MAILED TO FDA ON: 10/23/2008.
Description of Event or Problem · 1
A TECHNICIAN REPORTED A PATIENT WITH AN UNEXPECTED POSTOPERATIVE REFRACTION FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY. IN A FOLLOW-UP, THE SURGEON REPORTS THE OUTCOME OF THE EVENT AS "EXCELLENT".
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACRYSOF TORIC | INTRAOCULAR LENS | MJP | ALCON RESEARCH, LTD. | SN60T4 | 955096 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 83 YR | Other |