FDA Adverse Event
Other
Summary report: N
ACRYSOF RESTOR
MDR report key: 1431930
·
Received July 31, 2009
Report
- Report Number
- 1119421-2009-00726
- Event Type
- Other
- Date Received
- July 31, 2009
- Date of Event
- July 1, 2009
- Report Date
- July 2, 2009
- 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
- IL, US
- 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 ON 07/14/2009 AND 07/21/2009 BY PHONE. MEDICAL RECORDS WERE RECEIVED ON 07/02/2009. THIS REPORT WAS MAILED TO FDA ON: 07/31/2009.
Description of Event or Problem · 1
A TECHNICIAN REPORTED A PATIENT WITH AN UNEXPECTED POSTOPERATIVE REFRACTION FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACRYSOF RESTOR | INTRAOCULAR LENS | MFK | ALCON RESEARCH, LTD. / HUNTINGTON | SN6AD1 | 10873553 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR | Other | NABUMETONE| FLOMAX| DIOVAN| VYTORIN| METFORMIN| AVANDIA| ASPIRIN |