BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS CL IOL

    MDR report key: 12456557 · Received September 10, 2021

    Report

    Report Number
    2020664-2021-07332
    Event Type
    Malfunction
    Date Received
    September 10, 2021
    Date of Event
    August 12, 2021
    Report Date
    December 7, 2021
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    UDI-DI
    05050474530751
    PMA / PMN Number
    P880081
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: PRODUCT TESTING COULD NOT BE PERFORMED SINCE THE PRODUCT WAS NOT RETURNED FOR EVALUATION. HOWEVER, EVALUATION OF THE PHOTO PROVIDED WAS DONE. THIS EVALUATION CONCLUDED THAT THE SUSPECTED Z9002 IMPLANTED IOL SHOWED A DARK AND IRREGULAR LINE, WHICH DOES NOT INCLUDE THE EDGE OF THE LENS, LEAVING A SMALL AMOUNT OF THE LENS INTACT. THIS OBSERVATION MAY BE COMPATIBLE WITH THE OBSERVATION CLAIMED BY THE CUSTOMER THAT THE IOL LENS TORE. NEVERTHELESS, THE ROOT CAUSE AND POTENTIAL CLINICAL IMPLICATIONS CAN NOT BE ASSESSED FROM A PICTURE ASSESSMENT. MANUFACTURING RECORDS REVIEW: THE MANUFACTURING RECORDS FOR THE PRODUCT WERE REVIEWED. THE PRODUCT WAS MANUFACTURED AND RELEASED ACCORDING TO SPECIFICATION. A SEARCH REVEALED THAT NO ADDITIONAL COMPLAINT WAS RECEIVED FROM THIS PRODUCTION ORDER. 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

    AGE OR DATE OF BIRTH, WEIGHT, AND ETHNICITY: UNKNOWN, INFORMATION NOT PROVIDED. IF IMPLANTED, GIVE DATE: NOT APPLICABLE, AS LENS WAS REMOVED/REPLACED IN THE INITIAL SURGERY. IF EXPLANTED, GIVE DATE: NOT APPLICABLE, AS LENS WAS REMOVED/REPLACED IN THE INITIAL SURGERY. THE DEVICE WAS NOT RETURNED FOR ANALYSIS AS THE LENS WAS DISCARDED. THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED. A REVIEW OF THE DEVICE HISTORY RECORD, COMPLAINT TRENDING, AND RISK DOCUMENTATION FOR THIS DEVICE WILL BE PERFORMED. UPON COMPLETION OF THE REVIEW, IF THERE IS ANY FURTHER RELEVANT INFORMATION A SUPPLEMENTAL MEDWATCH WILL BE FILED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SURGEON IMPLANTED THE INTRAOCULAR LENS (IOL) INTO PATIENT'S OPERATIVE EYE, HOWEVER, A TEAR IN THE OPTIC WAS OBSERVED AND THE LENS WAS REMOVED AND REPLACED WITH ANOTHER LENS OF SAME MODEL DURING THE SAME PROCEDURE. THE REPORTER STATED THE TEAR WAS MOST LIKELY DUE TO A LOADING ISSUE, HOWEVER, COULD NOT BE CONFIRMED. THERE WAS NO HARM TO THE PATIENT AND NO INTERVENTION WAS REQUIRED. THE REMOVED LENS IS NOT AVAILABLE FOR RETURN. NO FURTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1352157 TECNIS CL IOL INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. Z9002 05050474530751

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown