BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELASTIC LENS

    MDR report key: 628544 · Received August 19, 2005

    Report

    Report Number
    2023826-2005-01145
    Event Type
    Malfunction
    Date Received
    August 19, 2005
    Date of Event
    December 9, 2004
    Report Date
    August 2, 2005
    Manufacturer
    STAAR SURGICAL CO.
    Product Code
    HQL
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE LAF CARD FOR THIS AA4204VF PLATE SILICONE LENS WAS RETURNED WITHOUT ANY PREVIOUS ALLEGATION OF PRODUCT PROBLEM. A CALL WAS MADE TO THE USER FACILITY AND THE REPORTER STATED THAT THE SURGEON ATTEMPTED TO INSERT THIS LENS. THE LENS HAPTIC TORE PRIOR TO INSERTION INTO THE EYE. THERE WAS PATIENT CONTACT. NO PATIENT INJURY. IT WAS UNKNOWN WHAT CAUSED THE HAPTIC TO TEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ELASTIC LENS INTRAOCULAR LENS HQL STAAR SURGICAL CO. AA4204VF NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN