BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HUMPHREY INSTRUMENT

    MDR report key: 349265 · Received August 24, 2001

    Report

    Report Number
    349265
    Event Type
    Injury
    Date Received
    August 24, 2001
    Date of Event
    July 16, 2001
    Report Date
    August 21, 2001
    Manufacturer
    ZEISIS HUMPHREY SYSTEM
    Product Code
    HLN
    Report Source
    User Facility report
    Reporter Location
    AL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    ON AUGUST 7, 2001, IT WAS DISCOVERED THAT PT WOULD NEED SURGERY TO REPLACE LENS THAT WAS INSERTED IN THE PT'S LEFT EYE. VISION IN LEFT EYE WAS 20/70 PRE OPERATIVE. VISION IN LEFT EYE WAS 20/400. PRE-OPERATIVE AXIAL LENGTH WAS 24.31. RECHECK OF AXIAL LENGTH WAS 22.99. USING THE SAME ULTRASONIC BIOMETER. CALIBRATION WAS CHECKED AND WAS CORRECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    38808 HUMPHREY INSTRUMENT ULTRASONIC BIOMETER HLN ZEISIS HUMPHREY SYSTEM 820 *

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention