FDA Adverse Event
Other
Summary report: N
ACRYSOF RESTOR
MDR report key: 1211491
·
Received October 23, 2008
Report
- Report Number
- 1119421-2008-00833
- Event Type
- Other
- Date Received
- October 23, 2008
- Date of Event
- January 1, 2008
- Report Date
- September 23, 2008
- Manufacturer
- ALCON RESEARCH, LTD /HUNTINGTON
- Product Code
- MFK
- PMA / PMN Number
- P040020
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- 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. A COMPLETED QUESTIONNAIRE HAS NOT BEEN RECEIVED.
Description of Event or Problem · 1
A SURGEON REPORTED HAVING A PATIENT WITH BLURRED VISION, DIFFICULTY WITH INTERMEDIATE DISTANCE VISION AND AN INCREASED CONTRAST SENSITIVITY FOLLOWING BILATERAL INTRAOCULAR LENS (IOL) IMPLANT SURGERY. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENT. THIS REPORT IS FOR THE RIGHT EYE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACRYSOF RESTOR | INTRAOCULAR LENS | MFK | ALCON RESEARCH, LTD /HUNTINGTON | SN60D3 | 109609 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 57 YR | Other |