BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS 1-PIECE

    MDR report key: 2192371 · Received August 4, 2011

    Report

    Report Number
    2648035-2011-00152
    Event Type
    Injury
    Date Received
    August 4, 2011
    Date of Event
    June 28, 2011
    Report Date
    July 6, 2011
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQL
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INTRAOCULAR LENS WAS RECEIVED CUT IN 2 PIECES AND INSPECTED FOR THE REPORTED COMPLAINT OF A CRACK ON THE LOOP. INSPECTION OF THE RETURNED DEVICE WAS PERFORMED UNDER ILLUMINATED 10X MAGNIFICATION, THE COMPLAINT WAS NOT CONFIRMED, NEITHER OF THE 2 HAPTICS WERE CRACKED. A SCRATCH AND A CLEAR DRY SUBSTANCE WERE NOTED ON THE OPTIC. THIS CONDITION APPEARS TO BE RELATED TO USER HANDLING AND NOT TO THE INITIAL COMPLAINT REPORT. ALL PERTINENT INFORMATION AVAILABLE TO AMO HAS BEEN SUBMITTED. SHOULD NEW INFORMATION BE RECEIVED THAT CHANGES THE FACTS AND/OR CONCLUSION OF THIS REPORT, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    THE INTRAOCULAR LENS WAS NOT RECEIVED BY THE MANUFACTURER FOR ANALYSIS. PRIOR TO RELEASE TO THE MARKET THE LENS MET ALL MANUFACTURING SPECIFICATIONS. THE MANUFACTURER WAS NOT ABLE TO DEFINITIVELY DETERMINE IF THE INCISION WAS ENLARGED TO REMOVE THE IMPLANTED LENS. ALL KNOWN INFORMATION IS INCLUDED IN THIS REPORT. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. NOT RECEIVED BY THE MANUFACTURER.

    Description of Event or Problem · 1

    THE ACCOUNT REPORTED THE HAPTIC ON THE INTRAOCULAR LENS APPEARED TO BE CRACKED AFTER IMPLANT INTO THE PATIENT'S EYE. THE LENS WAS REMOVED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other