BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS SIMPLICITY

    MDR report key: 12544885 · Received September 28, 2021

    Report

    Report Number
    2020664-2021-07519
    Event Type
    Malfunction
    Date Received
    September 28, 2021
    Date of Event
    September 2, 2021
    Report Date
    December 8, 2021
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    UDI-DI
    05050474731806
    PMA / PMN Number
    P980040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: INFORMATION RECEIVED BY MANUFACTURING SITE THAT SURGEON'S NAME IS DR. K. GOSLIN. ALSO, EVENT DATE WAS SEP 2, 2021. THEREFORE, FIELDS BELOW UPDATED. SECTION B3: DATE OF EVENT:(B)(6) 2021. SECTION D9: DEVICE AVAILABLE FOR EVALUATION: YES. SECTION D9: RETURNED TO MANUFACTURER ON: OCT 4, 2021. SECTION H3: DEVICE EVALUATED BY MANUFACTURER: YES. DEVICE EVALUATION: THE PRODUCT WAS RETURNED TO THE MANUFACTURING SITE FOR EVALUATION. A PUNCTURE WAS OBSERVED IN THE SEALED POUCH CONTAINING THE COMPLAINT HANDPIECE AND IOL. SAMPLE WAS RECEIVED IN ITS FOLDING CARTON PACKAGE WITH LABELS PATIENT CARD AND IMPLANT CARD. FOLDING CARTON BOX WAS OBSERVED DAMAGE/BROKEN. A PUNCTURE WAS OBSERVED IN THE SEALED POUCH CONTAINING THE COMPLAINT HANDPIECE AND IOL. THE COMPLAINT ISSUE WAS CONFIRMED, HOWEVER THE COMPLAINT ISSUE WAS FURTHER INVESTIGATED. IT WAS DETERMINED THAT BASED ON THE RETURN CONDITION OF THE PRODUCT "IT IS POSSIBLE THAT THESE BOXES AND POUCHES WERE DAMAGED AND BROKEN DURING SHIPPING", AND THEREFORE CANNOT BE CONFIRMED TO BE RELATED TO MANUFACTURING AND NO PRODUCT DEFICIENCY COULD BE IDENTIFIED. THERE IS NO INFORMATION OF THE SHIPPING BOX AND IF IT WAS DAMAGED DURING SHIPMENT BY THE CARRIER. BASED ON THE INCOMPLETE INFORMATION, NO FURTHER INVESTIGATION COULD BE PERFORMED. MANUFACTURING RECORD REVIEW: THE MANUFACTURING RECORDS FOR THE INTRAOCULAR LENS WERE REVIEWED. THE PRODUCT WAS MANUFACTURED AND RELEASED ACCORDING TO SPECIFICATION. THE SEARCH REVEALED NO ADDITIONAL INVESTIGATION REQUEST (IR) FOR THIS PRODUCTION ORDER NUMBER HAS BEEN RECEIVED. 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

    DATE OF EVENT: UNKNOWN, NOT PROVIDED. IF IMPLANTED, GIVE DATE: NOT APPLICABLE, AS THERE IS NO INDICATION THAT THE LENS WAS IMPLANTED. IF EXPLANTED, GIVE DATE: NOT APPLICABLE, AS THERE IS NO INDICATION THAT THE LENS WAS IMPLANTED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TWO PRELOADED INTRAOCULAR LENSES (IOLS) WERE STERILE COMPROMISED AS THE PACKAGING WAS NOT FULLY INTACT. ONE OF THE LENS PACKAGE HAD A LITTLE HOLE BY THE KNOB AND THE OTHER WAS COMPLETELY RIPPED AT THE FOLD BY THE KNOB. THE DEVICES WERE NOT DAMAGED. HOWEVER, ONE BOX LOOKED LIKE IT MIGHT HAVE BEEN DAMAGED DURING SHIPPING, BUT THE SERIAL NUMBER OF THE BOX COULD NOT BE CONFIRMED. THERE WAS NO PATIENT CONTACT WITH THE LENSES. THROUGH FOLLOW-UP, IT WAS CLARIFIED THAT THE STERILE POUCH WAS DAMAGED ON BOTH IOLS. THE BOX WAS DAMAGED ON JUST ONE OF THE LENS. NO FURTHER INFORMATION WAS AVAILABLE. THIS REPORT CAPTURES ONE OF THE LENS AND A SEPARATE REPORT IS BEING SUBMITTED FOR THE OTHER LENS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1441834 TECNIS SIMPLICITY INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. DIB00 05050474731806

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown