BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILICONE ULTRAVIOLET-ABSORING POSTERIOR CHAMBER 3 PC FOLADABLE INTRAOCULAR LENS

    MDR report key: 1840868 · Received September 15, 2010

    Report

    Report Number
    2023826-2010-00915
    Event Type
    Injury
    Date Received
    September 15, 2010
    Date of Event
    August 24, 2010
    Report Date
    August 31, 2010
    Manufacturer
    STAAR SURGICAL CO.
    Product Code
    HQL
    PMA / PMN Number
    P900048
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - INCISION SUTURED: EVALUATION RESULTS: VISUAL INSPECTION OF THE RETURNED PRODUCT FOUND THE LENS OPTIC TORN, WITH PIECES TORN OFF AND MISSING. THERE WAS EVIDENCE OF CLEAR SURGICAL RESIDUE. CONCLUSIONS: BASED ON THE COMPLAINT HISTORY AND THE EVALUATION OF THE RETURNED PRODUCT, THE MOST LIKELY CAUSE OF THE EVENT WAS DUE TO A LOADING ERROR. (B)(4).

    Description of Event or Problem · 1

    THE REPORTER STATED THE SURGEON INSERTED AN AQ2015A SILICONE ASPHERIC THREE PIECE LENS AND THE LENS OPTIC BROKE. THE INCISION WAS ENLARGED TO REMOVE THE LENS. SUTURES WERE REQUIRED TO CLOSE THE INCISION. THE REPORTER STATED THE LENS OPTIC WAS BROKEN WHEN THE TECHNICIAN WAS LOADING THE LENS INTO THE CARTRIDGE AND WAS NOT NOTICED UNTIL AFTER THE LENS WAS INSERTED INTO THE PT'S EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SILICONE ULTRAVIOLET-ABSORING POSTERIOR CHAMBER 3 PC FOLADABLE INTRAOCULAR LENS INTRAOCULAR LENS HQL STAAR SURGICAL CO. AQ2015A NA

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Required Intervention INJECTOR MODEL: MSI-PM, LOT # UNK| CARTRIDGE MODEL: AQ CARTRIDGE FP, LOT # 1252979