BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS 1-PIECE

    MDR report key: 2981626 · Received February 27, 2013

    Report

    Report Number
    2648035-2013-00104
    Event Type
    Injury
    Date Received
    February 27, 2013
    Date of Event
    February 8, 2013
    Report Date
    February 11, 2013
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQL
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    THE INTRAOCULAR LENS (IOL) WAS RETURNED TO THE MANUFACTURER. VISUAL INSPECTION: THE RETURNED SAMPLE WAS INSPECTED AT 10X MICROSCOPE MAGNIFICATION. THE LENS WAS DAMAGED: THE OPTIC WAS CUT AND CRACKED AND A BROKEN HAPTIC WAS OBSERVED. THE CONDITIONS OBSERVED ARE CONSISTENT WITH A LENS THAT HAS BEEN EXPLANTED. ALSO, LENS HAD SURFACE RESIDUALS ADHERED TO BOTH SIDES OF OPTIC BODY COMPATIBLE WITH HANDLING THE LENS OUT OF STERILE ENVIRONMENT. NO MANUFACTURING RELATED ISSUE WAS IDENTIFIED. THE CONDITION OF DAMAGED LENS DID NOT ALLOW PERFORMING DIOPTER MEASUREMENT. AT THE TIME OF MANUFACTURE THE LENS WAS MEASURED FOR DIOPTER POWER, RESOLUTION AND CONTRAST AND FOUND TO BE WITHIN SPECIFICATION. ALL PERTINENT INFORMATION AVAILABLE TO THE MANUFACTURER HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT AN IMPLANTATION OF AN INTRAOCULAR LENS (IOL) WHICH WAS EXPLANTED IN A SECONDARY PROCEDURE IN THE SAME DAY DUE TO PATIENT PREFERENCE REGARDING THE DIOPTER SIZE. IT WAS STATED THAT THERE WAS AN INCISION ENLARGEMENT. PATIENT REPORTED TO BE DOING WELL. IT WAS STATED THAT THERE WAS NO ISSUE ATTRIBUTED TO THE QUALITY OF THE LENS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    83367 TECNIS 1-PIECE MONOFOCAL IOLS HQL ABBOTT MEDICAL OPTICS ZCB00

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention