BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS SIMPLICITY

    MDR report key: 11449814 · Received March 10, 2021

    Report

    Report Number
    2648035-2021-07343
    Event Type
    Malfunction
    Date Received
    March 10, 2021
    Date of Event
    February 10, 2021
    Report Date
    June 25, 2021
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    UDI-DI
    05050474635852
    PMA / PMN Number
    P980040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION D9. DEVICE AVAILABLE FOR EVALUATION? YES RETURNED TO MANUFACTURER ON: 5/19/2021 SECTION H3. DEVICE EVALUATED BY MANUFACTURER? YES DEVICE EVALUATION: AFTER THE VISUAL EVALUATION PERFORMED THE FOLLOWING ARE THE OBSERVATIONS: LENS WAS OUT OF THE DEVICE. THE LENS SURFACE WAS COVERED WITH VISCOELASTIC RESIDUES AND THE BODY LENS IS COMPLETELY; NO HAPTIC DETACHED WAS IDENTIFIED. NO DAMAGE TO THE CARTRIDGE TIP WAS OBSERVED, SOME RESIDUES OF VISCOELASTIC WERE PRESENT. THE PLUNGER AND PUSH ROD WERE PARTIALLY ADVANCED POSITION. THE COMPLAINT ISSUE WAS NOT VERIFIED. THE CONDITION IN WHICH THE SAMPLE RETURNED IS CONSISTENT WITH A PRODUCT THAT WAS HANDLED AND PREPARED FOR A SURGICAL PROCESS. NO PRODUCT QUALITY DEFICIENCY WAS IDENTIFIED. 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

    DEVICE EVALUATION: THE PRODUCT WAS NOT RETURNED. THEREFORE, THE SAMPLE EVALUATION COULD NOT BE PERFORMED, AND THE REPORTED ISSUE COULD NOT BE VERIFIED. NO PRODUCT DEFICIENCY 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 ADDITIONAL 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 · 1

    IF IMPLANTED, GIVE DATE: UNKNOWN, INFORMATION NOT PROVIDED. IF EXPLANTED, GIVE DATE: UNKNOWN, INFORMATION NOT PROVIDED. 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) LOADED INCORRECTLY AND WOULD NOT INSERT COMPLETELY, AND KEPT POPPING OUT OF THE INCISION. ALSO, THE LENS WOULD NOT ADVANCE APPROPRIATELY INTO THE PATIENT'S EYE VIA THE CARTRIDGE. THE SECOND LENS USED (SAME MODEL AND DIOPTER) DID ADVANCE APPROPRIATELY. THERE WAS NO INCISION ENLARGEMENT, VITRECTOMY, OR SUTURES REQUIRED. THERE WAS NO PATIENT INJURY REPORTED. POST-OP PATIENT WAS STABLE WITH NO PAIN. NO OTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352764 TECNIS SIMPLICITY INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. DCB00 05050474635852

    Patients

    Seq Age Sex Outcome Treatment
    1 CARTRIDGE MODEL AND LOT# UNKNOWN| CARTRIDGE MODEL AND LOT# UNKNOWN