BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS OPTIBLUE 1-PIECE

    MDR report key: 6351974 · Received February 23, 2017

    Report

    Report Number
    2648035-2017-00354
    Event Type
    Malfunction
    Date Received
    February 23, 2017
    Report Date
    March 21, 2017
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQL
    UDI-DI
    05050474546868
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE AVAILABLE FOR EVALUATION? YES. RETURNED TO MANUFACTURER ON: 02/16/2017. DEVICE RETURNED TO MANUFACTURER? YES. DEVICE EVALUATION: THE INTRAOCULAR LENS (IOL) WAS RETURNED AT THE MANUFACTURING SITE FOR EVALUATION. VISUAL INSPECTION SHOWED A SMALL DOT ADHERED TO THE OPTIC ZONE. THE PARTICLE WAS ANALYSED USING THE FOURIER TRANSFORM INFRARED (FTIR) SPECTROSCOPY. THE RESULTS REVEALED THAT THE DEBRIS WAS CONSISTENT WITH POLYCARBONATE. THE CUSTOMER'S REPORTED COMPLAINT OF DEBRIS ON THE DEVICE WAS VERIFIED. DURING THE MANUFACTURING PROCESS, THE LENSES MAY HAVE INDIRECT EXPOSURE TO THIS TYPE OF MATERIAL, POLYCARBONATE. BASED ON THE EVIDENCE OBSERVED IN THE INVESTIGATION, IT WAS NOT POSSIBLE TO CONFIRM IF THE DEBRIS (MATERIAL) WAS RELATED TO MANUFACTURING OR WAS A RESULT OF THE LENS BEING HANDLED BY THE SURGERY SITE. 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 INVESTIGATION REQUESTS FOR THIS ORDER NUMBER HAVE BEEN RECEIVED. LABELING REVIEW: THE DIRECTIONS FOR USE (DFU) WERE REVIEWED. THE DFU ADEQUATELY PROVIDES INSTRUCTIONS AND PRECAUTIONS ALONG WITH WARNINGS FOR THE PROPER USE AND HANDLING OF THE DEVICE. THE DFU 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. 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 UPON OPENING THE LENS CASE A WHITE DEBRIS WAS NOTICED ON THE OPTIC OF THE INTRAOCULAR LENS (IOL). REPORTEDLY, THE SURGEON DID NOT USE THE LENS. NO PATIENT CONTACT OR INJURY REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    135864 TECNIS OPTIBLUE 1-PIECE MONOFOCAL IOLS HQL ABBOTT MEDICAL OPTICS ZCB00V 05050474546868

    Patients

    Seq Age Sex Outcome Treatment
    1