BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELASTIC LENS

    MDR report key: 206338 · Received January 13, 1999

    Report

    Report Number
    2023826-1999-00001
    Event Type
    Injury
    Date Received
    January 13, 1999
    Date of Event
    December 7, 1998
    Report Date
    January 12, 1999
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    HQL
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT UNDERWENT CATARACT SURGERY ON 12/7/98, AND IMPLANATATION OF A STAAR MODEL AA-4203VF INTRAOCULAR LENS. HOWEVER, AFTER LENS INSERTION THE SURGEON NOTICED THAT THE POSTERIOR CAPSULE WAS TORN. THE SURGEON REMOVED THE LENS, PERFORMED AN ANTERIOR VITRECTOMY AND IMPLANTED ANOTHER LENS. THE DR FEELS THE LENS WAS AT FAULT. HOWEVER, THE LENS WAS RETURNED AND EVALUATED AND SHOWN TO HAVE NO DEFECTS PRESENT. THEREFORE, THIS EVENT IS CONSIDERED TO BE DUE TO USER ERROR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ELASTIC LENS Implant INTRAOCULAR LENS HQL STAAR SURGICAL COMPANY AA4203VF 1118024

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention