BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS SYMFONY

    MDR report key: 11144204 · Received January 10, 2021

    Report

    Report Number
    2648035-2021-07052
    Event Type
    Malfunction
    Date Received
    January 10, 2021
    Date of Event
    December 10, 2020
    Report Date
    March 12, 2021
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    POE
    UDI-DI
    05050474574700
    PMA / PMN Number
    P980040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: IN REVIEW OF SECTION E IN FOLLOW-UP 1, THE COUNTRY WAS INADVERTENTLY SELECTED AS UNITED STATES, HOWEVER, THE COUNTRY SHOULD HAVE BEEN GERMANY. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    SECTION D10 - DEVICE AVAILABLE FOR EVALUATION? YES. SECTION D10 - RETURNED TO MANUFACTURER ON: 2/4/2021. 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 CUT IN HALF, WHICH IS CONSISTENT WITH A LENS THAT WAS HANDLED DURING REMOVAL AND REPLACEMENT. BASED ON THE RETURN CONDITION OF THE LENS, NO FURTHER PRODUCT EVALUATION COULD BE PERFORMED. THE COMPLAINT ISSUE COULD NOT BE CONFIRMED, AND NO PRODUCT DEFICIENCY COULD BE IDENTIFIED. 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

    AGE OR DATE OF BIRTH, WEIGHT, ETHNICITY: INFORMATION UNKNOWN/ NOT PROVIDED. IF IMPLANTED; GIVE DATE: IMPLANT DATE DOES NOT APPLY BECAUSE THE LENS WAS REMOVED DURING THE SAME PROCEDURE. IF EXPLANTED; GIVE DATE: EXPLANT DATE DOES NOT APPLY BECAUSE THE LENS WAS REMOVED DURING THE SAME PROCEDURE AND HAS NEVER BEEN IMPLANTED. PHONE: (B)(6). ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN OPENING THE LENS BLISTER THE OPERATING ROOM ASSISTANT NOTICED THAT THERE WAS APPARENTLY NO LENS IN THE BLISTER IN THE INTENDED POSITION. AFTER CAREFULLY EXAMINING THE BLISTER, THE INTRAOCULAR LENS (IOL) WAS DISCOVERED INSIDE THE ROTATING THREAD AND THE EMPLOYEE MANAGED TO GET IT OUT OF THIS POSITION AND PLACE IT IN THE SHOOTER. THIS IOL WAS IMPLANTED, HOWEVER, AFTER IMPLANTATION THE SURGEON DISCOVERED SCRATCHES OR FURROWS ON THE LENS, WHICH MAY BE DUE TO THE IOL SLIPPING OUT OF ITS ACTUAL POSITION INTO THE THREAD INSIDE THE PACKAGING. BY SLIDING THE BLISTER BACK AND FORTH TO GET THE IOL OUT OF THIS POSITION, THE LENS MAY HAVE GOTTEN THESE SCRATCHES. THE SURGEON THEN IMMEDIATELY REMOVED THIS DAMAGED IOL AND INSERTED THE STANDBY IOL. THE PATIENT DID NOT NOTICE ANY OF THIS, THE EYE WAS NOT AFFECTED, THE REPLACEMENT PROCEEDED VERY QUICKLY AND WITHOUT COMPLICATIONS. STANDBY IOL USED WAS ALSO ZXT225, 25.0 DIOPTER. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    41127 TECNIS SYMFONY EXTENDED DEPTH OF FOCUS INTRAOCULAR LENS POE AMO PUERTO RICO MFG. INC. ZXT225 05050474574700

    Patients

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