FDA Adverse Event
Other
Summary report: N
ACRYSOF IQ TORIC
MDR report key: 1421700
·
Received July 24, 2009
Report
- Report Number
- 1119421-2009-00704
- Event Type
- Other
- Date Received
- July 24, 2009
- Date of Event
- June 2, 2009
- Report Date
- June 24, 2009
- 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
- TN, 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 06/25/2009, 07/08/2009, 07/13/2009, AND 07/14/2009 BY PHONE, FAX, AND MAIL. A COMPLETED QUESTIONNAIRE WAS RECEIVED ON 07/01/2009. THIS REPORT WAS MAILED TO FDA ON: 07/24/2009.
Description of Event or Problem · 1
A SURGEON REPORTED A PT WITH AN UNEXPECTED POSTOPERATIVE REFRACTION FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY. THE SURGEON REPORTED MILD POSTERIOR CAPSULE OPACIFICATION HAD BEEN NOTED. IN A FOLLOW UP, THE SURGEON REPORTED THE EVENT CONTINUES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACRYSOF IQ TORIC | INTRAOCULAR LENS | MJP | ALCON RESEARCH, LTD./HUNTINGTON | SN6AT4 | 10900622 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 53 YR | Other | VISCOELASTIC |