BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCUSCAN RXP

    MDR report key: 2052575 · Received April 8, 2011

    Report

    Report Number
    2028159-2011-00342
    Event Type
    Injury
    Date Received
    April 8, 2011
    Date of Event
    October 15, 2010
    Report Date
    March 9, 2011
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CENTER
    Product Code
    IYO
    PMA / PMN Number
    K842757
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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 INFORMATION BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED THAT THE DEVICE REPORTED AN INCORRECT MEASUREMENT, WHICH LED TO AN UNEXPECTED POST-OPERATIVE REFRACTIVE ERROR. THE ISSUE WAS RESOLVED WITH AN INTRAOCULAR LENS EXCHANGE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention DISCOVISC| TRADIZEX| VIGAMOX