FDA Adverse Event
Other
Summary report: N
ACRYSOF
MDR report key: 642892
·
Received October 21, 2005
Report
- Report Number
- 1119421-2005-00327
- Event Type
- Other
- Date Received
- October 21, 2005
- Date of Event
- February 11, 2005
- Report Date
- September 22, 2005
- Manufacturer
- ALCON LABORATORIES, INC./HUNTINGTON
- Product Code
- HQL
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- NO INFORMATION
Narratives
Description of Event or Problem · 1
ADDITIONAL INFORMATION WAS PROVIDED. THE SURGEON REPORTS THAT THE PT HAS A GOOD PROGNOSIS. THERE WAS NO UNPLANNED MEDICAL OR SURGICAL INTERVENTION REQUIRED AND THE SURGEON DOES NOT FEEL THAT THE LOL(S) CAUSED/CONTRIBUTED TO THE PT'S SYSMPTOMS.
Description of Event or Problem · 1
A PT REPORTS EXPERIENCING HALOS, PHOTOPHOBIA AND POR VISUAL ACUITY FOLLOWING INTRAOCULAR LENS IMPLANT SURGERY. SHE STATES THAT SHE REQUIRES PRISMS IN HER SPECTACLES. SHE REPORTS EXPERIENCING DIPLOPIA, GLARE AND SHIMMERING WHEN EXPOSED TO FLUORESCENT LIGHTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACRYSOF | INTRAOCULAR LENS | HQL | ALCON LABORATORIES, INC./HUNTINGTON | SA60AT | 807922 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 47 YR | Other |