BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS ITEC PRELOADED 1-PIECE IOL

    MDR report key: 3112343 · Received May 14, 2013

    Report

    Report Number
    2648035-2013-00216
    Event Type
    Injury
    Date Received
    May 14, 2013
    Date of Event
    April 19, 2013
    Report Date
    April 24, 2013
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQL
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING RECORDS FOR THE INTRAOCULAR LENS (IOL) SHOWED THAT THE PRODUCTION ORDER WAS MANUFACTURED ACCORDING TO SPECIFICATIONS. ALL PROCESS OPERATIONS WERE IN COMPLIANCE AND ALL TESTS RESULTS SHOWED A PASS CONDITION. NO DEVIATIONS OR NONCONFORMANCES (NCR) WERE REPORTED. EXPIRATION DATE: 01/11/2014. (B)(6). DEVICE MANUFACTURE DATE: 01/11/2013. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN INJECTING THE INTRAOCULAR LENS (IOL) INTO THE PATIENT'S EYE, THE SURGEON NOTICED THAT THE PRELOADED IOL HAD A TORN OPTIC. THE SURGEON HAD TO ENLARGE THE INCISION TO REMOVE THE IOL AND REPLACED IT WITH ANOTHER LENS. NO PATIENT INJURY OR CONSEQUENCE. THE LENS WAS IMPLANTED INTO THE RIGHT EYE. THE EXPLANTED IOL WAS DISCARDED. NO FURTHER INFORMATION AVAILABLE OR PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212185 TECNIS ITEC PRELOADED 1-PIECE IOL MONOFOCAL IOLS HQL ABBOTT MEDICAL OPTICS PCB00

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention