BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SILICONE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER THREE PIECE FOLDABLE INTRAOCULA

    MDR report key: 2980139 · Received February 21, 2013

    Report

    Report Number
    2023826-2013-00145
    Event Type
    Malfunction
    Date Received
    February 21, 2013
    Date of Event
    January 30, 2013
    Report Date
    January 31, 2013
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    HQL
    PMA / PMN Number
    P900048
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS - A VISUAL INSPECTION OF THE RETURNED PRODUCT FOUND A PARTIAL PIECE OF THE OPTIC IS TORN OFF AND MISSING. THERE WAS EVIDENCE OF CLEAR SURGICAL RESIDUE. CONCLUSION - BASED ON THE COMPLAINT HISTORY AND THE EVAL OF THE RETURNED PRODUCT, IT WAS DETERMINED THAT THE ROOT CAUSE OF THIS EVENT WAS DUE TO LOADING ERROR. (B)(4).

    Description of Event or Problem · 1

    THE REPORTER STATED THE SURGEON INSERTED AN AQ5010V THREE PIECE SILICONE LENS. THE LENS EXITED THE CARTRIDGE WRONG AND SURGEON COULD NOT GET IT SEATED PROPERLY IN THE EYE. THE LENS WAS REMOVED WITHOUT ANY PT INJURY AND ANOTHER SAME MODEL LENS WAS IMPLANTED. THE REPORTER STATED THE INCIDENT WAS CAUSED BY THE MISPLACEMENT OF THE LENS IN THE CARTRIDGE WHILE LOADING ALONG WITH THE SURGEON'S PREFERENCE TO REMOVE THE LENS AND IMPLANT ANOTHER LENS. NO ALLEGATIONS AGAINST THE PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    75177 SILICONE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER THREE PIECE FOLDABLE INTRAOCULA INTRAOCULAR LENS HQL STAAR SURGICAL COMPANY AQ5010V NA

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR INJECTOR MODEL AND LOT NUMBER - UNK| CARTRIDGE MODEL AND LOT NUMBER - UNK