BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS OPTIBLUE ITEC PRELOADED 1-PIECE IOL

    MDR report key: 5982414 · Received September 28, 2016

    Report

    Report Number
    2648035-2016-01524
    Event Type
    Malfunction
    Date Received
    September 28, 2016
    Date of Event
    September 6, 2016
    Report Date
    November 10, 2016
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQL
    UDI-DI
    05050474561571
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE AVAILABLE FOR EVALUATION? YES. RETURNED TO MANUFACTURER ON: 10/13/2016. DEVICE RETURNED TO MANUFACTURER? YES. DEVICE EVALUATION: THE PRELOADED DELIVERY SYSTEM WAS RETURNED AT THE MANUFACTURING SITE FOR EVALUATION. VISUAL INSPECTION AT 10X MICROSCOPE MAGNIFICATION SHOWED NO INTRAOCULAR LENS (IOL) INSIDE THE DEVICE. VISCOELASTIC RESIDUES WERE OBSERVED. NO CARTRIDGE DEFECTS OR TIP DEFORMED OR DAMAGED WERE OBSERVED. STRETCH MARKS WERE OBSERVED WHICH ARE TYPICALLY CAUSED OR MAY APPEAR BY THE PASS OF THE IOL THROUGH THE CARTRIDGE. THE CUSTOMER'S REPORTED COMPLAINT WAS NOT VERIFIED. MANUFACTURING RECORDS REVIEW: THE MANUFACTURING RECORDS FOR THE INTRAOCULAR LENS WERE REVIEWED. THE PRODUCT WAS MANUFACTURED AND RELEASED ACCORDING TO SPECIFICATION. A SEARCH REVEALED THAT NO ADDITIONAL COMPLAINTS FOR THIS ORDER NUMBER HAVE BEEN RECEIVED. LABELING REVIEW: THE DIRECTIONS FOR USE (DFU) WERE REVIEWED. THE DIRECTIONS FOR USE (DFU) ADEQUATELY PROVIDES INSTRUCTIONS AND PRECAUTIONS ALONG WITH WARNINGS FOR THE PROPER USE AND HANDLING OF THE DEVICE. AS A RESULT OF THE INVESTIGATION THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY AND THE REPORTED ISSUE COULD NOT BE VERIFIED. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    IF EXPLANTED, GIVE DATE: NOT APPLICABLE AS THERE IS NO INDICATION THAT THE LENS WAS EXPLANTED. (B)(6). THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, INTRAOCULAR LENS (IOL) MODEL NUMBER PCB00V THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE UNITED STATES, IOL MODEL NO. PCB00, WHICH FALLS UNDER PMA P980040 ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER THE IMPLANTATION OF AN INTRAOCULAR LENS (IOL), SOMETHING LIKE A SCRATCH MARK WAS OBSERVED ON THE OPTIC. THE SURGEON ALSO NOTICED THAT THE TIP OF THE CARTRIDGE, USED FOR THE IMPLANT, WAS DAMAGED. NO PATIENT INJURY REPORTED. ADDITIONAL INFORMATION WAS RECEIVED AND IT WAS LEARNT THAT THE SCRATCH MARK WAS OBSERVED AT THE ROOT PART OF THE TRAILING HAPTIC. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    636066 TECNIS OPTIBLUE ITEC PRELOADED 1-PIECE IOL MONOFOCAL IOLS HQL ABBOTT MEDICAL OPTICS PCB00V 05050474561571

    Patients

    Seq Age Sex Outcome Treatment
    1