BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILICONE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER THREE PIECE FOLDABLE INTRAOCULA

    MDR report key: 1241159 · Received November 20, 2008

    Report

    Report Number
    2023826-2008-01393
    Event Type
    Injury
    Date Received
    November 20, 2008
    Date of Event
    October 14, 2008
    Report Date
    October 27, 2008
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    HQL
    PMA / PMN Number
    P900048
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL INSPECTION OF THE RETURNED PRODUCT SHOWED THAT THE LENS WAS TORN INTO PIECES AND A HAPTIC WAS TORN OFF FROM THE OPTIC AND MISSING. THERE WAS EVIDENCE OF A CLEAR SURGICAL RESIDUE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SURGEON INSERTED AN AQ2010V THREE PIECE SILICONE LENS AND THE TRAILING HAPTIC TORE OFF AND REMAINED IN THE INJECTOR DURING INSERTION. THE INCISION WAS ENLARGED TO REMOVE THE LENS AND SUTURED AFTER THE BACK UP LENS WAS IMPLANTED. THE REPORTER INDICATED THAT THE INCIDENT WAS DUE TO A LOADING ERROR.

    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 AQ2010V NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention STAARVISC II| INJECTOR: MODEL MSI-PM| CARTRIDGE: MODEL AQ CARTRIDGE-FP