BEUDAMED
    FDA Adverse Event Other Summary report: N

    SEE H-10

    MDR report key: 1610813 · Received February 3, 2010

    Report

    Report Number
    2023826-2010-00106
    Event Type
    Other
    Date Received
    February 3, 2010
    Date of Event
    January 6, 2010
    Report Date
    January 6, 2010
    Manufacturer
    STARR SURGICAL COMPANY
    Product Code
    HQL
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SURGEON WAS INSERTING A CQ2015A THREE PIECE COLLAMER LENS, AND AS IT WAS UNFOLDING IN THE EYE, DAMAGE WAS NOTED. THE LENS WAS REMOVED AND REPLACED WITHOUT ANY PATIENT INJURY. THE REPORTER STATED, THE LENS WAS DAMAGED DURING LOADING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SEE H-10 INTRAOCULAR LENS HQL STARR SURGICAL COMPANY CQ2015A NA

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR LOT NUMBER UNK| INJECTOR MODEL MSI-PM,| CARTRIDGE MODEL CQ CARTRIDGE-FP,| LOT NUMBER UNK