BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS OPTIBLUE ITEC PRELOADED 1-PIECE IOL

    MDR report key: 5951163 · Received September 14, 2016

    Report

    Report Number
    2648035-2016-01453
    Event Type
    Malfunction
    Date Received
    September 14, 2016
    Date of Event
    August 14, 2016
    Report Date
    October 27, 2016
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQL
    UDI-DI
    05050474561878
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EXPLANT DATE: IF EXPLANTED, GIVE DATE: NOT APPLICABLE AS THERE IS NO INDICATION THAT THE LENS WAS EXPLANTED. INITIAL. CONTACT NAME: UNKNOWN, NOT PROVIDED. PHONE NUMBER: (B)(6). P,A 510(K): 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.

    Additional Manufacturer Narrative · 1

    DEVICE AVAILABLE FOR EVALUATION? YES. RETURNED TO MANUFACTURER ON: 09/06/2016. 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 EVIDENCE OF VISCOELASTIC RESIDUES, OVD (OPHTHALMIC VISCOSURGICAL DEVICE). NO INTRAOCULAR LENS (IOL) WAS OBSERVED INSIDE THE DEVICE. NO CRACK OR BROKEN PARTS ON THE CARTRIDGE SECTION WAS OBSERVED. NO DEBRIS/PARTICLES OR FOREIGN MATERIAL WERE OBSERVED IN THE CARTRIDGE COMPONENT. THE PARTICLE WAS ANALYSED USING THE FOURIER TRANSFORM INFRARED (FTIR) SPECTROSCOPY. THE RESULTS REVEALED THAT THE PARTICLE WAS CONSISTENT WITH ABS (ACRYLONITRILE/BUTADIENE/STYRENE). THE PLUNGER COMPONENT MATERIAL IS ABS. 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 A POTENTIAL INDICATION OF A PRODUCT QUALITY DEFICIENCY. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT JUST AFTER THE IMPLANTATION OF AN INTRAOCULAR LENS (IOL), A DEBRIS, BELIEVED TO BE A PART OF THE CARTRIDGE'S TIP, WAS OBSERVED IN THE PATIENT'S EYE. THE SURGEON REMOVED IT WITH THE SURGICAL FORCEPS. REPORTEDLY THE OPERATION WAS COMPLETED SAFELY. NO PATIENT INJURY REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    602841 TECNIS OPTIBLUE ITEC PRELOADED 1-PIECE IOL MONOFOCAL IOLS HQL ABBOTT MEDICAL OPTICS PCB00V 05050474561878

    Patients

    Seq Age Sex Outcome Treatment
    1