FDA Adverse Event
Other
Summary report: N
ACRYSOF RESTOR
MDR report key: 726842
·
Received June 15, 2006
Report
- Report Number
- 1119421-2006-00187
- 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
- CA, US
- Reporter Occupation
- NOT APPLICABLE
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 PT IS COMPLAINING OF CLOUDY (BLURRY) NEAR AND DISTANCE VISION FOLLOWING UNILATERAL INTRAOCULAR LENS IMPLANT SURGERY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACRYSOF RESTOR | INTRAOCULAR LENS | HQL | ALCON LABORATORIES, INC. / HUNTINGTON | SA60D3 | 935337 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NO INFO | Other |