FDA Adverse Event
Other
Summary report: N
ACRYSOF RESTOR
MDR report key: 1941829
·
Received December 8, 2010
Report
- Report Number
- 1119421-2010-01359
- Event Type
- Other
- Date Received
- December 8, 2010
- Date of Event
- January 1, 2010
- Report Date
- November 8, 2010
- 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
- AL, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THE PRODUCT HAS NOT BEEN RECEIVED FOR EVAL. PRODUCT HISTORY RECORDS COULD NOT BE REVIEWED BECAUSE THE RPTR DID NOT PROVIDE A LENS SERIAL NUMBER, LOT NUMBER, OR ANY IDENTIFICATION TRACEABLE TO THE MFG DOCUMENTATION. AT THE CONSUMER'S REQUEST, THE SURGEON WAS NOT CONTACTED. (B)(4).
Description of Event or Problem · 1
A CONSUMER REPORTS HAVING FUZZY VISION AT ARMS LENGTH AND WORSE INTERMEDIATE AND DISTANT VISION FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY. AT THE CONSUMER'S REQUEST, THE SURGEON WAS NOT CONTACTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACRYSOF RESTOR | INTRAOCULAR LENS | MFK | ALCON RESEARCH, LTD./HUNTINGTON | SN6AD1 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 50 YR | Other |