BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SILICONE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER THREE PIECE FOLDABLE INTRAOCULA

    MDR report key: 1851088 · Received September 28, 2010

    Report

    Report Number
    2023826-2010-00982
    Event Type
    Malfunction
    Date Received
    September 28, 2010
    Report Date
    September 1, 2010
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    HQL
    PMA / PMN Number
    P900048
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE REPORTER STATED THE SURGEON INSERTED AN AQ5010V SILICONE THREE PIECE LENS AS A PIGGY-BACK LENS, BUT THE LENS WOULD NOT UNFOLD CORRECTLY IN THE PT'S EYE. THE LENS WAS REMOVED WITH NO PT INJURY, NO ENLARGED INCISION OR SUTURES. ANOTHER SAME MODEL LENS WAS IMPLANTED. THE MANUFACTURER'S LABELING DOES NOT ADDRESS THE PIGGYBACKING OF LENSES AND IS OFF-LABEL USE. THE SURGEON USED FORCEPS TO IMPLANT THE LENS.

    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