BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS IOL

    MDR report key: 11234838 · Received January 27, 2021

    Report

    Report Number
    2648035-2021-07129
    Event Type
    Malfunction
    Date Received
    January 27, 2021
    Date of Event
    December 21, 2020
    Report Date
    April 9, 2021
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    UDI-DI
    05050474558144
    PMA / PMN Number
    P980040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: SECTION H6: CORRECTION: HEALTH EFFECT - IMPACT CODE: IN INITIAL REPORT, THE HEALTH EFFECT - IMPACT CODE SHOULD HAVE INDICATED: 2199 - NO HEALTH CONSEQUENCES OR IMPACT SECTION H6: CORRECTION: HEALTH EFFECT - CLINICAL CODE: IN INITIAL REPORT, THE HEALTH EFFECT - CLINICAL CODE SHOULD HAVE INDICATED: 4582 - NO CLINICAL SIGNS, SYMPTOMS OR CONDITIONS ADDITIONAL INFORMATION: DEVICE EVALUATION: PRODUCT TESTING COULD NOT BE PERFORMED SINCE THE PRODUCT WAS NOT RETURNED FOR EVALUATION. THEREFORE, THE REPORTED ISSUE COULD NOT BE VERIFIED, AND PRODUCT QUALITY DEFICIENCY COULD NOT BE DETERMINED. MANUFACTURING RECORDS REVIEW: THE MANUFACTURING RECORDS FOR THE PRODUCT WERE REVIEWED. THE PRODUCT WAS MANUFACTURED AND RELEASED ACCORDING TO SPECIFICATION. A SEARCH REVEALED THAT ONE ADDITIONAL COMPLAINT WAS RECEIVED FROM THIS PRODUCTION ORDER, HOWEVER IT MET THE CRITERIA FOR NO FURTHER INVESTIGATION. 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 DOB, WEIGHT, ETHNICITY: UNKNOWN/ NOT PROVIDED. IMPLANT DATE: IF IMPLANTED, GIVE DATE: NOT APPLICABLE, AS LENS WAS NOT IMPLANTED. EXPLANT DATE: IF EXPLANTED, GIVE DATE: NOT APPLICABLE, AS LENS WAS NOT IMPLANTED, THEREFORE NOT EXPLANTED. TELEPHONE NUMBER: (B)(6), ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS WAS DAMAGED WHEN PRIMING. THERE WAS NO PATIENT CONTACT WITH THE PRODUCT. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    133987 TECNIS IOL INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. PCB00 05050474558144

    Patients

    Seq Age Sex Outcome Treatment
    1