BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS MONOFOCAL

    MDR report key: 1994211 · Received February 16, 2011

    Report

    Report Number
    2648035-2011-00019
    Event Type
    Injury
    Date Received
    February 16, 2011
    Date of Event
    January 13, 2011
    Report Date
    January 18, 2011
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQL
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INTRAOCULAR LENS (IOL) WAS NOT RECEIVED FOR ANALYSIS. IN FOLLOW-UP WITH THE ACCOUNT WE WERE NOT ABLE TO DETERMINE THE SPECIFIC CAUSE OF THIS EVENT. THE IOL MET ALL MANUFACTURING SPECIFICATIONS PRIOR TO RELEASE. ALL INFORMATION CURRENTLY AVAILABLE IS INCLUDED IN THIS REPORT. A SUPPLEMENT REPORT WILL BE FILED AS NECESSARY WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE

    Additional Manufacturer Narrative · 1

    IT WAS CONFIRMED WITH THE ACCOUNT THAT THE PATIENT'S POSTERIOR CAPSULE TORE DURING REMOVAL OF THE VISCOELASTIC FROM THE EYE AFTER IMPLANTATION OF THE INTRAOCULAR LENS (IOL). THE LENS WAS DISCARDED AT THE SURGERY CENTER. OUR INVESTIGATION REASONABLY SUGGESTS THIS EVENT WAS NOT DIRECTLY CAUSED BY THE IOL. IOL DISCARDED BY THE ACCOUNT

    Description of Event or Problem · 1

    THE REPORTER STATED THAT THE PATIENT'S POSTERIOR CAPSULE TORE AFTER INSERTION OF THE INTRAOCULAR LENS. THE LENS WAS REMOVED WITH NO PATIENT INJURY. A VITRECTOMY WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TECNIS MONOFOCAL MONOFOCAL IOL HQL ABBOTT MEDICAL OPTICS ZA9003

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention