BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS SYMFONY OPTIBLUE

    MDR report key: 7532171 · Received May 22, 2018

    Report

    Report Number
    9614546-2018-00490
    Event Type
    Injury
    Date Received
    May 22, 2018
    Date of Event
    March 26, 2018
    Report Date
    August 30, 2018
    Manufacturer
    JOHNSON AND JOHNSON SURGICAL VISION, INC.
    Product Code
    POE
    UDI-DI
    05050474610040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE AVAILABLE FOR EVALUATION? YES. RETURNED TO MANUFACTURER ON: 5/22/2018. DEVICE RETURNED TO MANUFACTURER? YES. DEVICE EVALUATION: THE PRODUCT WAS RECEIVED IN A POUCH IN A ZIP LOCK BAG AND WAS INSPECTED BY A QUALIFIED FINAL INSPECTION OPERATOR USING A 12X MAGNIFICATION. IT CAN BE SEEN THAT THE LENS IS CONTAMINATED AND THERE IS A PRINT OF A PAIR OF TWEEZERS ON IT. CONSIDERING THE CONDITION OF THE RETURN SAMPLE, THE COMPLAINT CANNOT BE CONFIRMED. MANUFACTURING RECORD REVIEW: THE MANUFACTURING PROCESS RECORD WAS EVALUATED AND NO DEVIATION WAS FOUND DURING PROCESS RELATED TO THE COMPLAINT ISSUE REPORTED. THERE WAS NO DISCREPANCY FOUND DURING THE MRR (MANUFACTURING RECORD REVIEW). THE PRODUCT WAS MANUFACTURED AND RELEASED ACCORDING TO SPECIFICATIONS. A SEARCH REVEALED THAT NO SIMILAR COMPLAINTS WERE RECEIVED FOR THIS PRODUCTION ORDER. LABELING REVIEW: THE DIRECTIONS FOR USE (DFU) WAS REVIEWED. THE DFU ADEQUATELY PROVIDES INSTRUCTIONS AND PRECAUTIONS FOR THE PROPER USE AND HANDLING OF THE PRODUCT. CONCLUSION: 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 JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(6). THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, INTRAOCULAR LENS (IOL) MODEL NUMBER ZXR00V THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE UNITED STATES, IOL MODEL NUMBER ZXR00, WHICH FALLS UNDER PMA P980040. (B)(4). ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INTRAOCULAR LENS (MODEL ZXR00V +14.0 DIOPTER) WAS IMPLANTED IN THE PATIENT''S OPERATIVE EYE ON (B)(6) 2018. REPORTEDLY, THE PATIENT COMPLAINED OF HAVING POOR VISIBILITY OF THEIR HANDS. THE LENS WAS EXPLANTED ON (B)(6) 2018, AND REPLACED WITH ANOTHER LENS, SAME MODEL DIFFERENT DIOPTER. NO PROBLEM WITH THE PATIENT'S EYESIGHT WITH A VISUAL ACUITY OF (10/16) POST OPERATE. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    377287 TECNIS SYMFONY OPTIBLUE MULTIFOCAL IOLS POE JOHNSON AND JOHNSON SURGICAL VISION, INC. ZXR00V 05050474610040

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention