BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS 1-PIECE

    MDR report key: 3230398 · Received July 16, 2013

    Report

    Report Number
    2648035-2013-00290
    Event Type
    Injury
    Date Received
    July 16, 2013
    Report Date
    June 22, 2013
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQL
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). (B)(4). TO DATE THE INTRAOCULAR LENS (IOL) REMAINS IMPLANTED. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED IN FOLLOW UP WITH THE SURGEON THAT THE PATIENT UNDERWENT A SECONDARY PROCEDURE APPROXIMATELY 3 MONTHS POST IMPLANT OF THE AMO INTRAOCULAR LENS (IOL) IMPLANT. THE SECONDARY PROCEDURE WAS A PIGGY BACK LENS IMPLANT; THE TYPE AND MODEL OF THE LENS WAS NOT PROVIDED. THE SURGEON INDICATED THAT THE PIGGY BACK LENS IMPLANT WAS DIRECTLY RELATED TO THE POST OPERATIVE REFRACTION THAT THE PATIENT EXPERIENCED. NO FURTHER INFORMATION WAS AVAILABLE FROM THE SURGEON. NO PATIENT IDENTIFIERS OR LENS SERIAL NUMBER, DATE OF IMPLANT, OR DATE OF THE SECONDARY PROCEDURE WERE PROVIDED. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED. PLACEHOLDER.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE SURGEON THAT HIS PATIENT HAD A REFRACTIVE SURPRISE OF -1.50. THERE WAS NO INDICATION OF WHICH EYE HAD REFRACTIVE SURPRISE OR WHAT THE TARGETED REFRACTION WAS. THE PATIENT WORK-UPS INDICATED AN A CONSTANT OF 119.65. RIGHT EYE (OD) TARGETED FOR 0.0 AND LEFT EYE (OS) TARGETED FOR -2.0. THE IMPLANT DATE WAS NOT PROVIDED. THE DATE OF THE EVENT WAS NOT PROVIDED. THE SERIAL NUMBER OF THE IMPLANTED LENS WAS NOT PROVIDED AT THE TIME OF SUBMITTING THE MEDICAL DEVICE REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    327961 TECNIS 1-PIECE MONOFOCAL IOLS HQL ABBOTT MEDICAL OPTICS ZCB00

    Patients

    Seq Age Sex Outcome Treatment
    1 Other