BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS SIMPLICITY

    MDR report key: 12699334 · Received October 26, 2021

    Report

    Report Number
    2020664-2021-07922
    Event Type
    Malfunction
    Date Received
    October 26, 2021
    Date of Event
    August 25, 2021
    Report Date
    October 26, 2022
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    UDI-DI
    05050474731820
    PMA / PMN Number
    P980040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION D9. DEVICE AVAILABLE FOR EVALUATION? YES. RETURNED TO MANUFACTURER ON: NOV 30, 2021. SECTION H3. DEVICE EVALUATED BY MANUFACTURER? YES. DEVICE EVALUATION: VISUAL INSPECTION UNDER MAGNIFICATION REVEALED VISCOELASTIC RESIDUE ON THE OPTIC BODY AND HAPTICS AND THAT THE LENS WAS RECEIVED STUCK TO THE PRINTED LABEL ON THE SIMPLICITY. FURTHER INSPECTION REVEALED THAT A HAPTIC WAS DETACHED AND FOUND INSIDE OF THE LENS MODULE (DETACHMENT CAN BE ATTRIBUTED TO HANDLING WHILE THE HAPTIC BEING FOUND IN THE MODULE CAN BE ATTRIBUTED TO RETURNING THE LENS ON THE HANDPIECE LABEL AND THE HAPTIC POTENTIALLY FALLING INTO THE MODULE DURING SHIPPING AND CANNOT BE CONFIRMED TO B RELATED TO MANUFACTURING) THE COMPLAINT ISSUE COULD NOT BE CONFIRMED AND NO PRODUCT DEFICIENCY COULD BE IDENTIFIED. MANUFACTURING RECORD REVIEW: THE MANUFACTURING PROCESS RECORD WAS EVALUATED AND REVEALED THAT THE PRODUCT WAS MANUFACTURED AND RELEASED ACCORDING TO SPECIFICATIONS. A SEARCH REVEALED THAT NO OTHER COMPLAINTS WERE RECEIVED FROM THIS PRODUCTION ORDER. CONCLUSION: AS A RESULT OF THE INVESTIGATION THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY AND THE REPORTED ISSUE COULD NOT BE VERIFIED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: SECTION H6: AS PART OF AN INTERNAL REVIEW OF OUR MDRS IT WAS IDENTIFIED THAT THE CODE ¿HEALTH EFFECT - IMPACT CODE: 2199 - NO HEALTH CONSEQUENCES OR IMPACT" WAS INADVERTENTLY NOT INCLUDED IN THE INITIAL MDR OR SUPPLEMENTAL MDR #1 REPORTS; THEREFORE, IT HAS BEEN CAPTURED IN THIS SUPPLEMENTAL MDR REPORT AND THE FOLLOWING FIELD WAS UPDATED ACCORDINGLY: HEALTH EFFECT - IMPACT CODE: 2199 - NO HEALTH CONSEQUENCES OR IMPACT. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    WEIGHT AND ETHNICITY: UNKNOWN/ NOT PROVIDED. IF IMPLANTED, GIVE DATE: NOT APPLICABLE, AS LENS WAS NOT IMPLANTED. IF EXPLANTED, GIVE DATE: NOT APPLICABLE, AS LENS WAS NOT IMPLANTED, THEREFORE NOT EXPLANTED. 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) WAS TORN DURING THE PROCEDURE. THERE WAS INCISION ENLARGEMENT. BACK-UP LENS WAS IMPLANTED TO COMPLETE THE PROCEDURE. NO OTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1595867 TECNIS SIMPLICITY INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. DIB00 05050474731820

    Patients

    Seq Age Sex Outcome Treatment
    1 Female