BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COLLAMER ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER THREE PIECE FOLDABLE INTRAOCULA

    MDR report key: 1081251 · Received July 24, 2008

    Report

    Report Number
    2023826-2008-00973
    Event Type
    Injury
    Date Received
    July 24, 2008
    Date of Event
    January 10, 2008
    Report Date
    June 25, 2008
    Manufacturer
    STAAR SURGICAL CO.
    Product Code
    HQL
    PMA / PMN Number
    P990013
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL CODES, RESULTS: VISUAL INSPECTION OF THE RETURNED PRODUCT SHOWED THAT THERE WAS A SUBSTANCE ON THE OPTIC AND A TEAR BY ONE OF THE HAPTICS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SURGEON IMPLANTED A CQ2015 THREE PIECE COLLAMER LENS IN 2007, AND WHEN THE PT RETURNED LATER IN THE YEAR, HE COMPLAINED OF VISION PROBLEMS. THE SURGEON DIALATED THE EYE AND OBSERVED A OPACITY ON THE LENS. THE LENS WAS REMOVED IN 2008, AND REPLACED WITH ANOTHER SAME MODEL LENS. THE REPORTER INDICATED THE PT IS DOING FINE NOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COLLAMER ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER THREE PIECE FOLDABLE INTRAOCULA INTRAOCULAR LENS HQL STAAR SURGICAL CO. CQ2015 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention CARTRIDGE MODEL UNK| INJECTOR MODEL UNK