BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS SIMPLICITY

    MDR report key: 11878679 · Received May 25, 2021

    Report

    Report Number
    2648035-2021-07893
    Event Type
    Malfunction
    Date Received
    May 25, 2021
    Date of Event
    April 16, 2021
    Report Date
    July 1, 2021
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    UDI-DI
    05050474636132
    PMA / PMN Number
    P980040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: SECTION B5 - PER ADDITIONAL INFORMATION RECEIVED ON 04 JUNE 2021 ACCOUNT VERIFIED THAT THE NURSE MADE A CLERICAL ERROR IN PROVIDING THE SUSPECT LENS SERIAL NUMBER (SN). THE LENS THAT WAS FAULTY/SUSPECT LENS IS SN (B)(6), NOT SN (B)(6) AS PROVIDED IN THE INITIAL REPORT. IN ADDITION, ACCOUNT VERIFIED THAT THE FAULTY LENS CONTACTED THE EYE BUT LENS WAS NOT INSERTED IN THE EYE OR PARTIALLY DELIVERED TO THE EYE DURING THE PROCEDURE. THE REPLACEMENT LENS SN (B)(6) OF THE SAME MODEL AND DIOPTER AS THE ORIGINAL LENS SN (B)(6) WAS IMPLANTED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY, NO FURTHER MEDICAL OR SURGICAL INTERVENTION WAS REQUIRED. THERE WAS NO VISUAL IMPAIRMENT TO THE PATIENT AS A RESULT OF THIS EVENT. THE PATIENT WAS REPORTEDLY DOING GOOD WHEN DISCHARGED. UPON FURTHER REVIEW OF THE FILE, IT WAS NOTED THAT THIS EVENT IS NO LONGER REPORTABLE AS THE LENS CONTACTED THE EYE BUT LENS WAS NOT REMOVED FROM THE EYE AS A RESULT OF THIS EVENT. CORRECTED DATA SECTION D4 - SERIAL NUMBER (B)(6); EXPIRATION DATE: NOVEMBER 13, 2023; UNIQUE IDENTIFIER (UDI) NUMBER: (B)(4). SECTION H4 - DEVICE MANUFACTURE DATE: NOVEMBER 13, 2020. 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 LENS WAS NOT IMPLANTED. IF EXPLANTED, GIVE DATE: NOT APPLICABLE, AS LENS WAS NOT IMPLANTED. TELEPHONE 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 AN INTRAOCULAR LENS (IOL) HAD UNFOLDING ISSUE AND WAS IN CONTACT WITH THE PATIENT'S EYE, THE LENS COULDN'T UNLOAD PROPERLY. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    777310 TECNIS SIMPLICITY INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. DCB00 05050474636132

    Patients

    Seq Age Sex Outcome Treatment
    1