BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROSTAAR INJECTOR

    MDR report key: 692100 · Received March 23, 2006

    Report

    Report Number
    2023826-2006-00333
    Event Type
    Malfunction
    Date Received
    March 23, 2006
    Date of Event
    February 6, 2006
    Report Date
    February 21, 2006
    Manufacturer
    STAAR SURGICAL CO.
    Product Code
    KYB
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE REPORTER STATED THAT THE SURGEON WAS LOADING OR ADVANCING A COMPETITOR'S LENS IN A INDIGO-P INJECTOR, PRIOR TO INSERTION AND THE SURGEON NOTICED THE LENS WAS GETTING DAMAGED. HE OPTED NOT TO USE THE LENS. THE REPORTER STATED THAT THE CAUSE OF THE LENS TEAR WAS DUE JTO THE INDIGO-P INJECTOR. NO PATIENT CONTACT OR INJURY. THIS IS ONE OF TWO INCIDENTS FOR THE SAME PATIENT. SEE MANUFACTURER REPORT NUMBER 2023826-2006-00334 FOR THE SECOND INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICROSTAAR INJECTOR INTRAOCULAR LENS FOLDERS AND INJECTORS KYB STAAR SURGICAL CO. INDIGO-P 1198175

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN