BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS IOL

    MDR report key: 11371138 · Received February 24, 2021

    Report

    Report Number
    2648035-2021-07296
    Event Type
    Malfunction
    Date Received
    February 24, 2021
    Report Date
    March 17, 2021
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    UDI-DI
    05050474558328
    PMA / PMN Number
    P980040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP CORRECTION REPORT WILL BE SUBMITTED. TO INCLUDE THE BELOW TYPE OF INVESTIGATION CODES, NOT INCLUDED IN THE INITIAL MEDWATCH REPORT SUBMITTED: SECTION H6: TYPE OF INVESTIGATION: 3331 - ANALYSIS OF PRODUCTION RECORDS. SECTION H6: TYPE OF INVESTIGATION: 4109 - HISTORICAL DATA ANALYSIS. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    IF IMPLANTED, GIVE DATE: N/A. LENS WAS NOT IMPLANTED. IF EXPLANTED, GIVE DATE: N/A. LENS WAS NOT IMPLANTED; THEREFORE, NOT EXPLANTED. PHONE: (B)(6). DEVICE EVALUATION: THE PRELOADED UNIT WAS NOT RETURNED FOR EVALUATION. THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE PERFORMED. MANUFACTURING RECORD EVALUATION: THE MANUFACTURING RECORDS FOR THE INTRAOCULAR LENS WERE REVIEWED. THE PRODUCT WAS MANUFACTURED AND RELEASED ACCORDING TO SPECIFICATION. A SEARCH REVEALED THAT NO ADDITIONAL COMPLAINTS FOR THIS ORDER NUMBER HAVE BEEN RECEIVED. CONCLUSION: AS A RESULT OF THE INVESTIGATION, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A MODEL PCB00 LENS WAS DEFECTIVE AND COULD NOT BE USED. LENS IS NOT AVAILABLE FOR COLLECTION AS IT HAS BEEN DESTROYED. IT IS UNKNOWN IF THERE WAS PATIENT CONTACT, HOWEVER NO PATIENT INJURY HAS BEEN REPORTED. NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    269516 TECNIS IOL INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. PCB00 05050474558328

    Patients

    Seq Age Sex Outcome Treatment
    1