FDA Adverse Event
Other
Summary report: N
ACRYSOF
MDR report key: 1211517
·
Received October 17, 2008
Report
- Report Number
- 1119421-2008-00817
- Event Type
- Other
- Date Received
- October 17, 2008
- Date of Event
- July 24, 2008
- Report Date
- September 19, 2008
- Manufacturer
- ALCON RESEARCH, LTD.
- Product Code
- HQL
- PMA / PMN Number
- P930014
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, 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 09/24/2008 BY FAX AND MAIL. A COMPLETED QUESTIONNAIRE WAS RECEIVED ON 10/06/2008.
Description of Event or Problem · 1
A SURGEON REPORTED HAVING A PATIENT EXPERIENCING TEMPORAL SHADOWS FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY. IN A FOLLOW-UP, THE SURGEON REPORTS THE PROGNOSIS FOR THE PATIENT IS "GOOD".
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACRYSOF | INTRAOCULAR LENS | HQL | ALCON RESEARCH, LTD. | SN60WF | 10808635 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other | VISCOELASTIC |