FDA Adverse Event
Other
Summary report: N
NI
MDR report key: 789742
·
Received November 30, 2006
Report
- Report Number
- 1119421-2006-00392
- Event Type
- Other
- Date Received
- November 30, 2006
- Report Date
- October 31, 2006
- Manufacturer
- ALCON LABORATORIES, INC./ HUNTINGTON
- Product Code
- HQL
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, 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. 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 SURGEON REPORTED HE HAS SEVERAL PATIENTS WITH NEGATIVE DYSPHOTOPSIA FOLLOWING INTRAOCULAR LENS IMPLANT SURGERY. ADDITIONAL INFO HAS BEEN REQUESTED INCLUDING THE NUMBER OF PATIENTS AFFECTED AND THE INTRAOCULAR LENS MODEL(S) USED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NI | INTRAOCULAR LENS | HQL | ALCON LABORATORIES, INC./ HUNTINGTON | NI | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NO INFO |