BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS OPTIBLUE ITEC PRELOADED 1-PIECE IOL

    MDR report key: 6892428 · Received September 25, 2017

    Report

    Report Number
    2648035-2017-01699
    Event Type
    Malfunction
    Date Received
    September 25, 2017
    Report Date
    October 21, 2017
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN, NOT PROVIDED. SERIAL #: UNKNOWN/NOT PROVIDED. CATALOG #: COMPLETE CATALOG NUMBER IS UNKNOWN SINCE SERIAL NUMBER WAS NOT PROVIDED. EXPIRATION DATE IS UNKNOWN SINCE SERIAL NUMBER WAS NOT PROVIDED. UDI IS UNKNOWN SINCE SERIAL NUMBER WAS NOT PROVIDED. IF IMPLANTED, GIVE DATE: UNKNOWN IF THE LENS WAS IMPLANTED. IF EXPLANTED, GIVE DATE: UNKNOWN IF THE LENS WAS IMPLANTED AND UNKNOWN IF EXPLANTED. INITIAL REPORTER: A CONTACT NAME WAS NOT PROVIDED. (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. MANUFACTURING DATE: UNKNOWN SINCE SERIAL NUMBER IS WAS NOT PROVIDED. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED AND IT WAS LEARNT THAT THE INTRAOCULAR LENS (IOL) WAS IMPLANTED 3 WEEKS PRIOR TO (B)(6) 2017. IT WAS REPORTED THAT THERE WERE TWO SCRATCH MARKS ON THE LENS AND TO DATE IT REMAINS IMPLANTED. ALSO THE SERIAL NUMBER OF LENS WAS PROVIDED. UPDATED THE FOLLOWING FIELDS: IF IMPLANTED, GIVE DATE: AN EXACT DATE WAS NOT PROVIDED, BUT THE BEST ESTIMATED DATE IS BETWEEN (B)(6) 2017. (B)(4), CATALOG #: PCB00V0180, EXPIRATION DATE: 03/24/2020, (B)(4). MANUFACTURING DATE: 03/24/2017. DEVICE EVALUATION: THE INTRAOCULAR LENS (IOL) WAS NOT RETURNED AT THE MANUFACTURING SITE; THEREFORE PRODUCT TESTING COULD NOT BE PERFORMED AND THE CUSTOMER'S REPORTED COMPLAINT COULD NOT BE 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A SCRATCH MARK ON THE OPTIC OF AN INTRAOCULAR LENS (IOL). NO PATIENT INJURY WAS REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    671868 TECNIS OPTIBLUE ITEC PRELOADED 1-PIECE IOL MONOFOCAL IOLS HQL ABBOTT MEDICAL OPTICS PCB00V

    Patients

    Seq Age Sex Outcome Treatment
    1