FDA Adverse Event
Other
Summary report: N
ACRYSOF
MDR report key: 789824
·
Received December 1, 2006
Report
- Report Number
- 1119421-2006-00396
- Event Type
- Other
- Date Received
- December 1, 2006
- Report Date
- November 1, 2006
- Manufacturer
- ALCON LABORATORIES, INC./ HUNTINGTON
- Product Code
- HQL
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
H.3., 6.: THE COMPLAINT DEVICE ASSOCIATED WITH THIS REPORT HAS NOT BEEN RECEIVED FOR EVALUATION. THE DEVICE REMAINS IMPLANTED. PRODUCT HISTORY RECORDS WERE REVIEWED AND ALL DOCUMENTS INDICATE THE PRODUCT MET RELEASE CRITERIA. THERE HAVE BEEN NO OTHER COMPLAINTS RECEIVED FOR THIS LOT NUMBER.
Description of Event or Problem · 1
A SURGEON REPORTS A PATIENT IS EXPERIENCING GLARE AND HALOS FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY. THE LENS IS PERFECTLY CENTERED AND THE PATIENT'S BCVA IS 20/20. PILOCARPINE DROPS ELIMINATED THE STREAKING GLARE, BUT NOT THE HALOS. THE PATIENT'S PUPIL IS VERY SMALL AND THE SURGEON IS DEBATING WHETHER A LENS EXCHANGE MAY BE BENEFICIAL. ADDITIONAL INFORMATION HAS BEEN REQUESTED INCLUDING THE PATIENT'S CURRENT STATUS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACRYSOF | INTRAOCULAR LENS | HQL | ALCON LABORATORIES, INC./ HUNTINGTON | SA60AT | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NO INFO | Other |