BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELASTIMIDE FOLDABLE SILICONE POSTERIOR CHAMBER INTRAOCULAR L

    MDR report key: 644609 · Received November 3, 2005

    Report

    Report Number
    2023826-2005-01515
    Event Type
    Injury
    Date Received
    November 3, 2005
    Date of Event
    October 4, 2005
    Report Date
    October 4, 2005
    Manufacturer
    STAAR SURGICAL CO.
    Product Code
    HQL
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE REPORTER STATED THAT THE SURGEON HAD IMPLANTED A SILICONE INTRAOCULAR LENS MODEL AQ2003V ON 6/21/2005 AND EXPLANTED THE LENS FROM PATIENTS EYE IN 2005 DUE TO A MISCALCULATION OF DIOPTRIC POWER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ELASTIMIDE FOLDABLE SILICONE POSTERIOR CHAMBER INTRAOCULAR L INTRAOCULAR LENS HQL STAAR SURGICAL CO. AQ2003V UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention