BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS IOL

    MDR report key: 11441431 · Received March 9, 2021

    Report

    Report Number
    2648035-2021-07336
    Event Type
    Malfunction
    Date Received
    March 9, 2021
    Report Date
    May 4, 2021
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    UDI-DI
    05050474558212
    PMA / PMN Number
    P980040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: PER ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER IT WAS NOTED THAT THE LENS WAS BROKEN DURING SHIPPING. THE OUTER SHIPPING BOX WAS BROKEN AND THE LENS PACKAGING WAS BENT. WHEN OPENED IT WAS NOTED THAT THE PLUNGER WAS BROKEN OFF FROM THE INJECTOR. THIS OCCURRED DURING SHIPPING, AND WAS NOT HANDED TO THE SURGEON. THEREFORE, THIS EVENT IS NO LONGER REPORTABLE AS THERE IS NO INDICATION OF A MALFUNCTION OR PRODUCT QUALITY DEFICIENCY. NO FURTHER INFORMATION RECEIVED. SECTION H3-OTHER (81): THE INTRAOCULAR LENS (IOL) WAS NOT RETURNED FOR EVALUATION: THE COMPLAINT IS NOT REPORTABLE AND CAUSE IS KNOWN THEREFORE, THERE IS NO INDICATION OF A MALFUNCTION OR PRODUCT QUALITY DEFICIENCY. NO NONCONFORMITY REPORT, ESCALATION, DOCUMENTATION OR LABELING CHANGE IS REQUIRED. AMO PUERTO RICO MANUFACTURING / JOHNSON AND JOHNSON SURGICAL VISION WILL CONTINUE TO MONITOR THIS TYPE OF COMPLAINTS. THE FOLLOWING SECTIONS HAVE BEEN UPDATED ACCORDINGLY: SECTION H6: MEDICAL DEVICE PROBLEM CODE: 2284 - DEVICE DAMAGED PRIOR TO USE. SECTION H6: TYPE OF INVESTIGATION: 4114 - DEVICE NOT RETURNED. SECTION H6: INVESTIGATION FINDINGS: 3221 - NO FINDINGS AVAILABLE. SECTION H6: INVESTIGATION CONCLUSIONS: 4308 - CAUSE TRACED TO TRANSPORT/STORAGE. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    AGE/DATE OF BIRTH, WEIGHT, ETHNICITY: UNKNOWN, INFORMATION NOT PROVIDED. DATE OF EVENT: UNKNOWN, NOT PROVIDED. IF IMPLANTED, GIVE DATE: UNKNOWN, INFORMATION NOT PROVIDED. IF EXPLANTED, GIVE DATE: UNKNOWN, INFORMATION NOT PROVIDED. PHONE NUMBER: (B)(6). FAX NUMBER: (B)(6). ATTEMPTS HAVE BEEN MADE TO OBTAIN MISSING INFORMATION; HOWEVER, TO DATE, NO RESPONSE HAS BEEN RECEIVED. 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 (IOL) WAS DAMAGED. NO FURTHER INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    341306 TECNIS IOL INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. PCB00 05050474558212

    Patients

    Seq Age Sex Outcome Treatment
    1