BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCUSCAN RXP

    MDR report key: 3830114 · Received May 1, 2014

    Report

    Report Number
    2028159-2014-00787
    Event Type
    Injury
    Date Received
    May 1, 2014
    Report Date
    April 4, 2014
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CTR
    Product Code
    IYO
    PMA / PMN Number
    K842757
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SERVICE REPORT HAS BEEN RECEIVED BUT THE INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFO BECOMES AVAILABLE. ADDITIONAL INFO HAS BEEN REQUESTED BUT NOT RECEIVED TO DATE. (B)(4).

    Description of Event or Problem · 1

    A HEALTHCARE PROFESSIONAL REPORTED THAT HE OBTAINED WRONG BIOMETRY RESULTS REGARDING THE INTRAOCULAR LENS (IOL) SELECTION. ALTHOUGH THE PT WAS EXPECTED TO BE EMMETROPIC, 30-40 DAYS AFTER SURGERY THE PT HAD +2D HYPEROPIA. ADDITIONAL INFO HAS BEEN REQUESTED BUT NOT RECEIVED TO DATE. THIS IS ONE OF THREE MEDICAL DEVICE REPORTS BEING FILED FOR THIS FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    262054 OCUSCAN RXP ULTRASONIC PULSED ECHO IMAGING SYSTEM IYO ALCON - IRVINE TECHNOLOGY CTR 8065741076 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other BIOMETRY PROBE