FDA Adverse Event
Other
Summary report: N
ACRYSOF TORIC
MDR report key: 1082241
·
Received July 23, 2008
Report
- Report Number
- 1119421-2008-00540
- Event Type
- Other
- Date Received
- July 23, 2008
- Date of Event
- June 1, 2008
- Report Date
- June 23, 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
- OR, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. RESULTS FROM THE PRODUCT HISTORY RECORD REVIEW INDICATED THE PRODUCT MET RELEASE CRITERIA. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THIS LOT NUMBER.
Description of Event or Problem · 1
A SURGEON REPORTED A PT HAD A POSTOPERATIVE SURPRISE AND THE PT STATED SHE SAW SHADOWS IN HER VISION FOUR MONTHS FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY. THE SURGEON STATED SHE DID NOT THINK THE IOL WAS DEFECTIVE. ADDITIONAL INFO HAS BEEN REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACRYSOF TORIC | INTRAOCULAR LENS | MJP | ALCON RESEARCH, LTD./HUNTINGTON | SN60T5 | 10732822 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NI | Other |