BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISIAN ICL (IMPLANTABLE COLLAMER LENS)

    MDR report key: 2250423 · Received September 15, 2011

    Report

    Report Number
    2023826-2011-00792
    Event Type
    Malfunction
    Date Received
    September 15, 2011
    Date of Event
    August 16, 2011
    Report Date
    August 18, 2011
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    HQL
    PMA / PMN Number
    P030016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SURGEON INSERTED A VICM13.2 IMPLANTABLE COLLAMER LENS ON (B)(6) 2011 AND THE LENS WAS EXCHANGED ON (B)(6) 2011 DUE TO INCORRECT POWER. THE REPORTER INDICATED IT WAS A SURGEON'S ERROR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VISIAN ICL (IMPLANTABLE COLLAMER LENS) INTRAOCULAR LENS HQL STAAR SURGICAL COMPANY VICM13.2 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention