BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS CL IOL

    MDR report key: 13447314 · Received February 3, 2022

    Report

    Report Number
    3012236936-2022-00299
    Event Type
    Malfunction
    Date Received
    February 3, 2022
    Date of Event
    January 13, 2022
    Report Date
    April 11, 2022
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    UDI-DI
    05050474530638
    PMA / PMN Number
    P880081
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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. 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. (B)(4). ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    SECTION D9: DEVICE AVAILABLE FOR EVALUATION: YES. SECTION D9: RETURNED TO MANUFACTURER ON: FEB 14, 2022. SECTION H3: DEVICE EVALUATED BY MANUFACTURER: YES. DEVICE EVALUATION: THE PRODUCT WAS RETURNED TO THE MANUFACTURING SITE FOR EVALUATION. THE COMPLAINT ISSUES (HAPTIC DETACHED) COULD BE CONFIRMED; HOWEVER, IT MAY BE ATTRIBUTED TO HANDLING DURING IMPLANTATION AND CANNOT BE CONFIRMED TO BE RELATED TO A MANUFACTURING/ DESIGN ISSUE AND NO PRODUCT DEFICIENCY COULD BE IDENTIFIED. ADDITIONAL CONDITIONS WERE OBSERVED (COSMETIC ISSUES); HOWEVER, THESE CONDITIONS CANNOT BE CONFIRMED TO BE RELATED TO THE MANUFACTURING/ DESIGN PROCESS. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS FULLY INSERTED INTO PATIENT'S LEFT EYE, HOWEVER, WAS REMOVED DURING THE SAME PROCEDURE AS THE FRONT HAPTIC BROKE OFF. THE INCISION WAS ENLARGED AND ANOTHER LENS OF SAME MODEL AND DIOPTER WAS USED AS THE REPLACEMENT. THE PATIENT WAS FINE POST OPERATION. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    904146 TECNIS CL IOL INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. Z9002 05050474530638

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Female PSCST30 LOT # CJ19880