BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS 1-PIECE

    MDR report key: 6741185 · Received July 25, 2017

    Report

    Report Number
    2648035-2017-01341
    Event Type
    Injury
    Date Received
    July 25, 2017
    Report Date
    September 13, 2017
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQL
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT - (B)(6) 2017. UDI# - (01)(21)UNKNOWN, SINCE SERIAL NUMBER OF THE DEVICE WAS NOT PROVIDED. CATALOG # - A COMPLETE CATALOG NUMBER UNKNOWN AS SERIAL NUMBER WAS NOT PROVIDED. SERIAL# - UNKNOWN SINCE PRODUCT IDENTIFICATION WAS NOT PROVIDED. EXPIRATION DATE - UNKNOWN SINCE SERIAL NUMBER OF THE DEVICE WAS NOT PROVIDED. MFG DATE - UNKNOWN SINCE SERIAL NUMBER OF THE DEVICE WAS NOT PROVIDED. (B)(4). CITATION: WRIGHT AJ, SINGH MK, HENRIKSEN BS, MCFADDEN M, OLSON RJ. TWO SINGLE-PIECE ACRYLIC INTRAOCULAR LENS CHOICES AND THEIR EFFECT ON PATIENT-REPORTED DRIVING HABITS. JOURNAL OF CATARACT AND REFRACTIVE SURGERY. 2017 FEB 2017;43(2):239-245. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE INTRAOCULAR LENS (IOL) WAS NOT RETURNED TO THE MANUFACTURING SITE. THEREFORE, PRODUCT TESTING COULD NOT BE PERFORMED AND THE CUSTOMER¿S REPORTED EVENT COULD NOT BE VERIFIED. MANUFACTURING RECORDS REVIEW: THE MANUFACTURING RECORD EVALUATION COULD NOT BE PERFORMED SINCE SERIAL NUMBER IS UNKNOWN, WAS NOT PROVIDED. LABELING REVIEW: THE DIRECTIONS FOR USE (DFU) WAS REVIEWED. THE 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

    LITERATURE FROM THE JOURNAL OF CATARACT AND REFRACTIVE SURGERY - TWO SINGLE-PIECE ACRYLIC INTRAOCULAR LENS CHOICES AND THEIR EFFECT ON PATIENT-REPORTED DRIVING HABITS. IT WAS REPORTED THAT 2 UNIDENTIFIED PATIENTS EXPERIENCED MODERATE OR EXTREME DIFFICULTY DRIVING AT NIGHT POST INTRAOCULAR LENS IMPLANTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    520287 TECNIS 1-PIECE MONOFOCAL IOLS HQL ABBOTT MEDICAL OPTICS ZCB00

    Patients

    Seq Age Sex Outcome Treatment
    1 Other