BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COLLAMER ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER SINGLE PIEC

    MDR report key: 668479 · Received January 26, 2006

    Report

    Report Number
    2023826-2006-00111
    Event Type
    Injury
    Date Received
    January 26, 2006
    Date of Event
    December 20, 2005
    Report Date
    December 28, 2005
    Manufacturer
    STAAR SURGICAL COMPANY
    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 SURGEON INSERTED A CC4204BF COLLAMER PLATE LENS IN 2005. THE LENS WAS REMOVED THE FOLLOWING DAY DUE TO THE WRONG LENS HAVING BEEN IMPLANTED, THE WRONG DIOPTER LENS WAS CHOSEN FOR SURGERY. THE INCISION WAS ENLARGED TO REMOVE THE LENS AND ANOTHER LENS WAS IMPLANTED. SUTURES WERE REQUIRED TO CLOSE THE WOUND. THIS IS ONE OF THE THREE LENSES THE SURGEON ATTEMPTED TO INSERT INTO THIS PATIENT - SEE MFG REPORT #2023826-2006-00110 AND 2023826-2006-00112.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COLLAMER ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER SINGLE PIEC INTRAOCULAR LENS HQL STAAR SURGICAL COMPANY CC4204BF NA

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention