BEUDAMED
    FDA Adverse Event Summary report: N

    SEE H-10

    MDR report key: 3191562 · Received June 26, 2013

    Report

    Report Number
    2023826-2013-00522
    Date Received
    June 26, 2013
    Date of Event
    June 5, 2013
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    HQL
    PMA / PMN Number
    P880091
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: VISUAL INSPECTION OF THE RETURNED LENS SHOWED A PIECE OF THE OPTIC AND A HAPTIC WAS TORN OFF AND MISSING. THERE WAS EVIDENCE OF A CLEAR SURGICAL RESIDUE, HOWEVER, THERE WAS NO VISIBLE DAMAGE TO THE CARTRIDGE. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER THE SURGEON INSERTED THE AQ2015A THREE PIECE SILICONE LENS AND PART OF THE OPTIC AND A HAPTIC WAS TORN OFF AND MISSING. THE REMAINDER OF THE LENS WAS CUT AND REMOVED FROM THE EYE WITHOUT ANY PATIENT COMPLICATIONS. ANOTHER AQ2015A LENS WAS SUCESSFULLY IMPLANTED. THE REPORTER STATED THE EVENT WAS THE RESULT OF LOADING ISSUES THEY WERE HAVING WITH NEW SURGERY TECHS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290089 SEE H-10 INTRAOCULAR LENS HQL STAAR SURGICAL COMPANY AQ2015A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 AQ CARTRIDGE-FP, LOT NUMBER 1279679