BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS 1 MULTIFOCAL

    MDR report key: 7338460 · Received March 14, 2018

    Report

    Report Number
    9614546-2018-00250
    Event Type
    Injury
    Date Received
    March 14, 2018
    Date of Event
    July 18, 2016
    Report Date
    May 14, 2018
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    Product Code
    MFK
    UDI-DI
    05050474560109
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: THE PRODUCT TESTING WAS NOT PERFORMED AS THE COMPLAINT DEVICE WAS NOT RETURNED FOR EVALUATION (THE IOL REMAINS IMPLANTED). THE REPORTED COMPLAINT CANNOT 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 SIMILAR 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. CONCLUSION: AS A RESULT OF THE INVESTIGATION THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    THE LENS REMAINS IMPLANTED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A ZKB00 21.0 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2016. IMMEDIATELY AFTER SURGERY, THE PATIENT EXPERIENCED SHADOWS AND BLURRED VISION THAT BECOMES WORSE IN BRIGHTER LIGHT, BUT IS ALSO EVIDENT IN LOW LIGHT. REPORTEDLY, THE DOCTOR RECOMMENDED THE PATIENT TO HAVE A YTTRIUM-ALUMINUM GARNET (YAG) PROCEDURE, WHICH SHE DID HAVE COMPLETED ON (B)(6) 2017, BUT IT DID NOT HELP. FURTHERMORE, THE PATIENT IS USING EYE DROPS BECAUSE THE DOCTOR THINKS THE PATIENT MAY HAVE DRY EYES. HOWEVER, THE PATIENT STATED THEY ARE NOT HELPING THE PROBLEM. NO ADDITIONAL INFORMATION WAS PROVIDED. THE PATIENT HAD BILATERAL LENSES IMPLANTED. THIS REPORT WILL CAPTURE THE LENS IMPLANTED IN THE PATIENT'S LEFT EYE. A SEPARATE REPORT WILL BE FILED FOR THE RIGHT EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    181002 TECNIS 1 MULTIFOCAL MULTIFOCAL IOLS MFK JOHNSON & JOHNSON SURGICAL VISION, INC. ZKB00 05050474560109

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Other