FDA Adverse Event
Other
Summary report: N
ACRYSOF
MDR report key: 1587856
·
Received January 15, 2010
Report
- Report Number
- 1119421-2010-00033
- Event Type
- Other
- Date Received
- January 15, 2010
- Date of Event
- December 1, 2009
- Report Date
- December 17, 2009
- Manufacturer
- ALCON RESEARCH. LTD. / HUNTINGTON
- Product Code
- HQL
- PMA / PMN Number
- P930014
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, 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 12/21/2009 AND 01/04/2010 BY PHONE, FAX, AND MAIL. ADDITIONAL INFORMATION WAS RECEIVED ON 01/07/2010. (B) (4). (B) (4). (B) (4).
Description of Event or Problem · 1
AN OPTOMETRIST REPORTED A PT EXPERIENCING MONOCULAR DIPLOPIA FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY. IN A FOLLOW-UP WITH THE IMPLANTING SURGEON, HE STATED THAT HE DOES NOT BELIEVE THE PT HAS MONOCULAR DIPLOPIA; RATHER THE PT MAY HAVE MINIMAL GHOST IMAGE FROM UNCORRECTED ASTIGMATISM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACRYSOF | INTRAOCULAR LENS | HQL | ALCON RESEARCH. LTD. / HUNTINGTON | SN60WF | 10929766 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |