FDA Adverse Event
Other
Summary report: N
ACRYSOF TORIC
MDR report key: 1182400
·
Received September 12, 2008
Report
- Report Number
- 1119421-2008-00705
- Event Type
- Other
- Date Received
- September 12, 2008
- Date of Event
- June 3, 2008
- Report Date
- August 13, 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
- MN, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THE PRODUCT WAS NOT RETURNED FOR ANALYSIS; THE DEVICE REMAINS IMPLANTED. RESULTS FROM THE PRODUCT HISTORY RECORDS REVIEW INDICATED THE PRODUCT MET RELEASE CRITERIA. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. ADDITIONAL INFORMATION WAS REQUESTED VIA PHONE ON 08/13/2008 AND VIA FAX AND MAIL ON 08/14/2008. A COMPLETED QUESTIONNAIRE WAS RECEIVED.
Description of Event or Problem · 1
A CONSUMER REPORTED HE EXPERIENCES FLASHES OF LIGHT IN THE CENTER OF HIS EYE WHEN HE MOVES HIS HEAD, FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY. THE SURGEON REPORTED PATIENT HAS POSSIBLE EDGE GLARE OR QUESTIONABLE POSTERIOR VITREAL DETACHMENT (PVD) EFFECT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACRYSOF TORIC | INTRAOCULAR LENS | MJP | ALCON RESEARCH, LTD./HUNTINGTON | SN60T4 | 10815576 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 61 YR | Other |