FDA Adverse Event
Other
Summary report: N
ACRYSOF
MDR report key: 726846
·
Received June 15, 2006
Report
- Report Number
- 1119421-2006-00186
- Event Type
- Other
- Date Received
- June 15, 2006
- Report Date
- May 16, 2006
- Manufacturer
- ALCON LABORATORIES, INC. / HUNTINGTON
- Product Code
- HQL
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GR
- Reporter Occupation
- NO INFORMATION
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 COULD NOT BE REVIEWED BECAUSE THE REPORTER DID NOT PROVIDE A LENS SERIAL NUMBER, LOT NUMBER, OR ANY IDENTIFICATION TRACEABLE TO THE MANUFACTURING DOCUMENTATION.
Description of Event or Problem · 1
A PT'S SON REPORTS HIS MORTHER IS HAVING PROBLEM WITH LIGHT FOLLOWING INTRAOCULAR LENS IMPLANT SURGERY. ALTHOUGH SHE SEES WELL, THE LIGHT IS BOTHERSOME AND SHE IS NOT COMFORTABLE. EVEN AT HOME, SHE FEELS LIKE SHE NEEDS TO WEAR SUNGLASSES. ARRANGEMENTS TO OBTAIN ADDITIONAL INFORMATION FROM THE IMPLANTING SURGEON HAVE BEEN REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACRYSOF | INTRAOCULAR LENS | HQL | ALCON LABORATORIES, INC. / HUNTINGTON | MA30BA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 47 YR | Other |