FDA Adverse Event Other Summary report: N

LEGACY SERIES 2000

MDR report key: 500584 · Received October 27, 2003

Report

Report Number
500584
Event Type
Other
Date Received
October 27, 2003
Date of Event
July 1, 2003
Report Date
August 1, 2003
Manufacturer
ALCON LABORATORIES, INC.
Product Code
HQC
Product Problem
Yes
Report Source
User Facility report
Reporter Location
IN, US
Reporter Occupation
OTHER

Narratives

Description of Event or Problem · 1

AFTER SCULPTING THE LENS OF THE RIGHT EYE, THE PHYSICAN SWITCHED TO BIOMODAL ON THE LEGACY CATERACT MACHINE. AT THIS TIME THE PHYSICIAN FELT THAT A SURGE OF FLUID ENTERED THE EYE. THE EQUIPMENT WAS IMPOUNDED AND TAKEN OUT OF SERVICE FOR FURTHER EXAMINATION.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 LEGACY SERIES 2000 CATARACT MACHINE HQC ALCON LABORATORIES, INC. LEGACY 2000 *

Patients

Seq Age Sex Outcome Treatment
1 63 YR Other