FDA Adverse Event
Injury
Summary report: N
ACRYSOF
MDR report key: 168686
·
Received May 21, 1998
Report
- Report Number
- 1119421-1998-00046
- Event Type
- Injury
- Date Received
- May 21, 1998
- Date of Event
- April 20, 1998
- Report Date
- April 20, 1998
- Manufacturer
- ALCON LABORATORIES, INC.
- Product Code
- HQL
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
H.6: THE EVALUATION OF THE EXPLANTED LENS REVEALED THAT THE OPTICAL QUALITY WAS ACCEPTABLE. THIS REPORT WAS MAILED IN TO FDA ON: 6/19/1998 DISCLAIMER: THIS INFO IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT AN ALCON LABORATORIES, INC. PRODUCT IS DEFECTIVE OR HAS CAUSED SERIOUS INJURY. NUMBER OF PERSONS AFFECTED = 1.
Description of Event or Problem · 1
SURGEON REPORTS LENS WAS REPLACED DUE TO GLARE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACRYSOF Implant | INTRAOCULAR LENS | HQL | ALCON LABORATORIES, INC. | MA60BM | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Required Intervention |