FDA Adverse Event
Injury
Summary report: N
ACRYSOF
MDR report key: 40208
·
Received September 24, 1996
Report
- Report Number
- 1119421-1996-00110
- Event Type
- Injury
- Date Received
- September 24, 1996
- Report Date
- August 28, 1996
- Manufacturer
- ALCON LABORATORIES, INC.
- Product Code
- HQL
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THE INITIAL REPORT WAS RECEIVED BY MFR ON 8/28/96. ADDITIONAL INFO WAS RECEIVED ON 10/25/96 NECESSITATING A SUPPLEMENTAL FILING. THIS REPORT WAS MAILED IN TO FDA ON: 11/22/96 DISCLAIMER: THIS INFO IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH 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
HOSP REPORTS HAPTIC BROKE DURING INSERTION AND INCISION HAD TO BE WIDENED IN ORDER TO FACILITATE REMOVAL OF THE LENS. DATE DEVICE EXPIRES: 5/31/2001.
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 |