BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILICONE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER THREE PIECE FOLDABLE INTRAOCULA

    MDR report key: 2063759 · Received April 14, 2011

    Report

    Report Number
    2023826-2011-00298
    Event Type
    Injury
    Date Received
    April 14, 2011
    Date of Event
    January 10, 2011
    Report Date
    March 24, 2011
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    HQL
    PMA / PMN Number
    P900048
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL METHOD: LENS WORK ORDER SEARCH. RESULTS: A LENS WORK ORDER SEARCH WAS PERFORMED AND NO SIMILAR COMPLAINTS WERE FOUND WITHIN THE SAME WORK ORDER. (B)(4).

    Description of Event or Problem · 1

    THE REPORTER STATED, THE SURGEON IMPLANTED A AQ5010V THREE PIECE SILICONE LENS IN THE PT'S LEFT EYE ON (B)(6) 2010. ADVERSE EVENT WAS OBSERVED ON (B)(6) 2011. THE LENS WAS RUBBING AGAINST IRIS LOCATION. LENS WAS REMOVED DUE TO PT HAVING PERSISTANT UVEITIS, INCREASED EYE PRESSURE AND POSSIBLE UVEITIS GLAUCOMA HYPHEMA SYNDROME. ADD'L SUTURE WAS USED AT TIME OF IOL REMOVAL. NO OTHER LENS WAS IMPLANTED. PT'S LAST VISIT ON (B)(6) 2011. CONTINUING WITH GLAUCOMA, ANTI-INFLAMMATORY AND STEROID DROPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SILICONE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER THREE PIECE FOLDABLE INTRAOCULA INTRAOCULAR LENS HQL STAAR SURGICAL COMPANY AQ5010V NA

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR