BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS SIMPLICITY

    MDR report key: 12533867 · Received September 27, 2021

    Report

    Report Number
    2020664-2021-07441
    Event Type
    Malfunction
    Date Received
    September 27, 2021
    Date of Event
    September 1, 2021
    Report Date
    November 1, 2021
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    UDI-DI
    05050474731769
    PMA / PMN Number
    P980040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: SECTION D9: DEVICE AVAILABLE FOR EVALUATION ¿ YES. RETURNED TO MANUFACTURER ON 10/4/2021. SECTION H3: DEVICE EVALUATED BY MANUFACTURER ¿ YES. DEVICE EVALUATION: VISUAL INSPECTED UNDER MAGNIFICATION REVEALED THAT THE IOL WAS RECEIVED STUCK IN THE CARTRIDGE WITH VISCOELASTIC RESIDUE IN THE CARTRIDGE. THE LENS WAS REMOVED AND CLEANED, AND LENS DAMAGE WAS OBSERVED. THE COMPLAINT ISSUE WAS CONFIRMED; HOWEVER, BASED ON THE FACT THAT THE LENS WAS HANDLED DURING REMOVAL FROM THE CARTRIDGE THIS MAY BE ATTRIBUTED TO HANDLING AND CANNOT BE CONFIRMED TO BE RELATED TO MANUFACTURING. THEREFORE, NO PRODUCT DEFICIENCY COULD BE IDENTIFIED. MANUFACTURING RECORDS REVIEW: THE MANUFACTURING RECORDS FOR THE PRODUCT WERE REVIEWED. THE PRODUCT WAS MANUFACTURED AND RELEASED ACCORDING TO SPECIFICATION. A SEARCH REVEALED ONE ADDITIONAL COMPLAINT FOLDERS FOR THIS PRODUCTION ORDER NUMBER: THE CONDITION REPORTED FOR ADDITIONAL COMPLAINT FOLDER IS NOT RELATED TO THE COMPLAINT ISSUE REPORTED. 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: NOT NEEDED AS THERE WAS NO PATIENT CONTACT OR IMPACT. IF IMPLANTED, GIVE DATE: NOT APPLICABLE, AS THERE WAS NO PATIENT CONTACT OR IMPACT. IF EXPLANTED, GIVE DATE: NOT APPLICABLE, AS THERE WAS NO PATIENT CONTACT OR IMPACT. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT INTRAOCULAR LENS (IOL) WAS FOUND DAMAGED. THERE WAS NO PATIENT CONTACT. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1432865 TECNIS SIMPLICITY INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. DIB00 05050474731769

    Patients

    Seq Age Sex Outcome Treatment
    1