BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS OPTIBLUE 1-PIECE

    MDR report key: 6412291 · Received March 17, 2017

    Report

    Report Number
    2648035-2017-00507
    Event Type
    Malfunction
    Date Received
    March 17, 2017
    Date of Event
    February 15, 2017
    Report Date
    May 3, 2017
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQL
    UDI-DI
    05050474546684
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE AVAILABLE FOR EVALUATION? YES. RETURNED TO MANUFACTURER ON: 03/28/2017. DEVICE RETURNED TO MANUFACTURER? YES. THE INTRAOCULAR LENS (IOL) WAS RETURNED AT THE MANUFACTURING SITE INSIDE THE LENS CASE. VISUAL INSPECTION AT 10X MICROSCOPE MAGNIFICATION SHOWED A FOREIGN MATERIAL, LIKE A HAIR, INSIDE THE LENS CASE. THE CUSTOMER'S REPORTED COMPLAINT WAS VERIFIED. THE MATERIAL AND THE LENS WERE SENT TO THE LAB FOR FURTHER ANALYSIS BUT THE HAIR-LIKE MATERIAL WAS NOT FOUND. A FRAGMENT OF DEBRIS THAT LOOKED LIKE A SHAVING WAS OBSERVED ON THE LENS. THE PARTICLE WAS ANALYSED USING THE FOURIER TRANSFORM INFRARED (FTIR) SPECTROSCOPY. THE RESULTS REVEALED THAT THE PARTICLE WAS CONSISTENT WITH POLYCARBONATE. POLYCARBONATE IS PART OF THE COMPONENTS OF THE DAISY WHEEL LENS CASE; HOWEVER, THIS COULD BE A PARTICLE FROM THE ENVIRONMENT, SINCE THE LENS WAS OPENED. MOREOVER THE LENS CASE WAS EVALUATED AND NO DAMAGES WERE OBSERVED. 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. THE DIRECTIONS FOR USE (DFU) ADEQUATELY PROVIDES INSTRUCTIONS AND PRECAUTIONS ALONG WITH WARNINGS FOR THE PROPER USE AND HANDLING OF THE DEVICE. THE DGU STATES TO EXAMINE THE LENS THOROUGHLY TO ENSURE PARTICLES HAVE NOT BECOME ATTACHED TO IT, AND EXAMINE THE LENS OPTICAL SURFACES FOR OTHER DEFECTS. 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

    (B)(6). THIS REPORT IS BEING FILED ON AN INTERNATIONAL DEVICE; TECNIS OPTIBLUE 1-PIECE IOL, THAT HAS A SIMILAR DEVICE, TECNIS 1-PIECE IOL MODEL ZCB00 WHICH IS DISTRIBUTED IN THE UNITED STATES UNDER PMA P980040. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A FOREIGN SUBSTANCE, LIKE A HAIR, WAS FOUND ON AN INTRAOCULAR LENS (IOL) UPON OPENING THE LENS CASE. REPORTEDLY, THE SURGEON DID NOT USE THE LENS. NO PATIENT CONTACT OR INJURY WAS REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    195672 TECNIS OPTIBLUE 1-PIECE MONOFOCAL IOLS HQL ABBOTT MEDICAL OPTICS ZCB00V 05050474546684

    Patients

    Seq Age Sex Outcome Treatment
    1