BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS 1-PIECE

    MDR report key: 2223786 · Received August 25, 2011

    Report

    Report Number
    2648035-2011-00185
    Event Type
    Injury
    Date Received
    August 25, 2011
    Date of Event
    July 25, 2011
    Report Date
    July 26, 2011
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQL
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ONE HALF OF AN INTRAOCULAR LENS WAS RECEIVED PRECLUDING MEASUREMENT OF THE DIOPTER. TWO DISTORTED HAPTICS WERE NOTED ON THE RETURNED PIECE. THE LENS MET ALL MANUFACTURING SPECIFICATIONS PRIOR TO RELEASE. IN FOLLOW-UP WITH THE ACCOUNT IT WAS LEARNED A LOWER DIOPTER LENS WAS IMPLANTED AND THE REMOVED LENS WAS NOT THE CAUSE OF THIS EVENT. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THE INTRAOCULAR LENS WAS EXPLANTED SEVERAL WEEKS AFTER IMPLANT. REASON STATED WAS REMOVAL WAS DUE TO A TARGET CHANGE. NO PATIENT COMPLICATIONS OCCURRED.

    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 Required Intervention