FDA Adverse Event
Other
Summary report: N
ACRYSOF RESTOR
MDR report key: 1821686
·
Received August 27, 2010
Report
- Report Number
- 1119421-2010-00939
- Event Type
- Other
- Date Received
- August 27, 2010
- Report Date
- July 29, 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
- GR
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THE PRODUCT WAS NOT RETURNED FOR ANALYSIS; DEVICE REMAINS IMPLANTED. PRODUCT HISTORY RECORDS COULD NOT BE REVIEWED BECAUSE THE REPORTER DID NOT PROVIDE A LOT NUMBER OR ANY IDENTIFICATION TRACEABLE TO THE MFG DOCUMENTATION. ADDITIONAL INFO HAS BEEN REQUESTED. (B)(4).
Description of Event or Problem · 1
ADVERSE EVENT(S): "BLURRED VISION" (BLURRED VISION). PRODUCT PROBLEM(S): "NONE REPORTED" (NO INFO [IOL (INTRAOCULAR LENS) IMPLANT]). A CONSUMER'S DAUGHTER REPORTED THAT FOLLOWING BILATERAL INTRAOCULAR LENS (IOL) IMPLANT SURGERIES, HER MOTHER IS EXPERIENCING BLURRED VISION. ADDITIONAL INFO HAS BEEN REQUESTED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENT. THIS REPORT IS FOR THE FELLOW EYE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACRYSOF RESTOR | INTRAOCULAR LENS | MFK | ALCON RESEARCH, LTD./HUNTINGTON | SN6AD1 | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NI | Other |