BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS SIMPLICITY

    MDR report key: 11396873 · Received March 1, 2021

    Report

    Report Number
    2648035-2021-07329
    Event Type
    Malfunction
    Date Received
    March 1, 2021
    Date of Event
    January 28, 2021
    Report Date
    March 30, 2021
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    UDI-DI
    05050474655409
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: IN REVIEW IT WAS OBSERVED THAT IN THE INITIAL REPORT SECTION G2 SHOULD HAVE INCLUDED FOREIGN AS A REPORT SOURCE. THEREFORE, FOREIGN IS NOW INDICATED IN SECTION G2. G2- FOREIGN ADDITIONAL INFORMATION: SECTION D9. DEVICE AVAILABLE FOR EVALUATION? YES RETURNED TO MANUFACTURER ON: 2/24/2021 SECTION H3. DEVICE EVALUATED TO MANUFACTURER? YES. DEVICE EVALUATION: THE PRELOADED UNIT WAS RETURNED FOR EVALUATION. A VISUAL INSPECTION USING MAGNIFICATION WAS PERFORMED. THE PLUNGER AND PUSHROD WAS OBSERVED IN ADVANCED POSITION. RESIDUES OF LUBRICATING MATERIAL WERE OBSERVED ON CARTRIDGE. THE CARTRIDGE TIP WAS OBSERVED DEFORMED. THE LENS RETURNED OUTSIDE THE PRELOADED DEVICE AND CUT IN TWO PIECES. BASED ON THE SAMPLE EVALUATION, THERE IS NO EVIDENCE TO SUGGEST THAT THE COMPLAINT UNIT HAS BEEN AFFECTED BY THE MANUFACTURING PROCESS. THE CONDITION IN WHICH THE SAMPLE RETURNED IS CONSISTENT WITH A PRODUCT THAT WAS HANDLED AND PREPARED FOR A SURGICAL PROCESS. DUE TO THE CONDITIONS OF THE LENS RETURNED, THE COMPLAINT ISSUE REPORTED COULD NOT BE VERIFIED. 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.

    Additional Manufacturer Narrative · 1

    IF IMPLANTED, GIVE DATE: NOT APPLICABLE, AS THE LENS WAS NOT IMPLANTED. IF EXPLANTED, GIVE DATE: NOT APPLICABLE, AS THE LENS WAS NOT IMPLANTED. THEREFORE, NOT EXPLANTED. PHONE NUMBER - (B)(4). ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LENS WAS DAMAGED, THE DEVICE WAS NOT IN CONTACT WITH THE PATIENT'S EYE, THE LENS WAS NOT IN CONTACT WITH THE PATIENT EYE, NO PATIENT INVOLVEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    293363 TECNIS SIMPLICITY INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. DIB00 05050474655409

    Patients

    Seq Age Sex Outcome Treatment
    1