FDA Adverse Event
Other
Summary report: N
ACRYSOF TORIC
MDR report key: 1023771
·
Received March 21, 2008
Report
- Report Number
- 1119421-2008-00167
- Event Type
- Other
- Date Received
- March 21, 2008
- Date of Event
- January 1, 2008
- Report Date
- February 21, 2008
- 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
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE PRODUCT WAS NOT RETURNED FOR ANALYSIS; THE DEVICE REMAINS IMPLANTED. PRODUCT HISTORY RECORDS COULD NOT BE REVIEWED BECAUSE THE REPORTER DID NOT PROVIDE A LENS SERIAL NUMBER, LOT NUMBER, OR ANY IDENTIFICATION TRACEABLE TO THE MANUFACTURING DOCUMENTATION. ADDITIONAL INFORMATION WAS REQUESTED 03/18/2008 BY MAIL AND FAX. A COMPLETED QUESTIONNAIRE HAS NOT BEEN RETURNED. THIS REPORT WAS MAILED TO FDA ON: 03/21/2008.
Description of Event or Problem · 1
A SURGEON REPORTS THAT HAVING A PATIENT WITH AN UNEXPECTED POSTOPERATIVE REFRACTION FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY. ADDITIONAL INFO HAS BEEN REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACRYSOF TORIC | INTRAOCULAR LENS | HQL | ALCON RESEARCH, LTD/HUNTINGTON | SN60T5 | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NI | Other |