BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SEE H-10

    MDR report key: 2983772 · Received February 28, 2013

    Report

    Report Number
    2023826-2013-00177
    Event Type
    Malfunction
    Date Received
    February 28, 2013
    Date of Event
    January 24, 2013
    Report Date
    January 30, 2013
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    HQL
    PMA / PMN Number
    P880091
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SILICONE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER THREE PIECE FOLDABLE INTRAOCULAR LENS (ELASTIMIDE). NO KNOWN IMPACT OR CONSEQUENCES TO THE PATIENT. SCRATCHED MATERIAL. (B)(4).

    Additional Manufacturer Narrative · 1

    RESULTS: VISUAL INSPECTION OF THE RETURNED LENS SHOWED THE OPTIC WAS TORN AND A PIECE OF THE OPTIC WAS TORN OFF WITH A HAPTIC AND MISSING. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE AQ2010V SILICONE THREE PIECE LENS WAS SCRATCHED. THE LENS WAS INSERTED AND REMOVED WITHOUT ANY PATIENT INJURY. THE REPORTER STATED THE EVENT WAS THE RESULT OF TECH/SURGEON'S ERROR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    88626 SEE H-10 INTRAOCULAR LENS HQL STAAR SURGICAL COMPANY AQ2010V N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR AQ CARTRIDGE-FP MODEL, LOT NUMBER UNKNOWN| MSI-TM INJECTOR MODEL, LOT NUMBER UNKNOWN