FDA Adverse Event
Other
Summary report: N
ACRYSOF TORIC
MDR report key: 937659
·
Received November 2, 2007
Report
- Report Number
- 1119421-2007-00445
- Event Type
- Other
- Date Received
- November 2, 2007
- Date of Event
- January 1, 2007
- Report Date
- October 4, 2007
- Manufacturer
- ALCON LABORATORIES, INC. / HUNTINGTON
- Product Code
- HQL
- PMA / PMN Number
- P930014
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, 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. ADD'L INFO WAS REQUESTED 10/5/2007 AND 10/16/2007 BY PHONE, FAX AND MAIL. ADDITIONAL INFO WAS RECEIVED 10/05/2007 AND 10/08/2007 BY FAX. A COMPLETED QUESTIONNAIRE HAS NOT BEEN RETURNED.
Description of Event or Problem · 1
A SURGEON REPORTS A PT WITH AN UNEXPECTED POSTOPERATIVE REFRACTION FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY. ADD'L INFO HAS BEEN REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACRYSOF TORIC | INTRAOCULAR LENS | HQL | ALCON LABORATORIES, INC. / HUNTINGTON | SN60T3 | 10715736 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NI YR | Other |