BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS IOL

    MDR report key: 15342232 · Received September 1, 2022

    Report

    Report Number
    3012236936-2022-02291
    Event Type
    Malfunction
    Date Received
    September 1, 2022
    Date of Event
    October 19, 2021
    Report Date
    October 4, 2022
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    UDI-DI
    05050474528833
    PMA / PMN Number
    P990080
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UNKNOWN; REQUESTED BUT NOT PROVIDED. IF EXPLANTED, GIVE DATE: NOT APPLICABLE, AS THERE WAS NO INDICATION THAT THE LENS WAS EXPLANTED. THE DEVICE WAS NOT RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED. A REVIEW OF THE DEVICE HISTORY RECORD, COMPLAINT TRENDING, AND RISK DOCUMENTATION FOR THIS DEVICE WILL BE PERFORMED. UPON COMPLETION OF THE REVIEW, IF THERE IS ANY FURTHER RELEVANT INFORMATION A SUPPLEMENTAL MEDWATCH WILL BE FILED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: UPON FURTHER REVIEW, IT WAS NOTED THAT IN THE INITIAL MDR SECTION H6, HAD THE INCORRECT HEALTH EFFECT - IMPACT CODE: 2199 - "NO HEALTH CONSEQUENCES OR IMPACT" WAS ENTERED. THE PREVIOUS CODE DOES NOT APPLY AS IT IS INDICATED THAT THE LENS WAS REMOVED AND REPLACED. THEREFORE, THIS SUPPLEMENTAL FILING IS TO CORRECT REPORT PREVIOUSLY PROVIDED. THE FOLLOWING FIELDS UPDATED: SECTION D6A: IF IMPLANTED, GIVE DATE: NOT APPLICABLE, AS IT WAS INDICATED THAT THE LENS WAS REMOVED/REPLACED DURING THE SAME PROCEDURE. SECTION D6B: IF EXPLANTED, GIVE DATE: NOT APPLICABLE, AS IT WAS INDICATED THAT THE LENS WAS REMOVED/REPLACED DURING THE SAME PROCEDURE. SECTION H6: HEALTH EFFECT: IMPACT CODE: 4631 (REMOVAL AND REPLACED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: SECTION D9: DEVICE AVAILABLE FOR EVALUATION? YES. SECTION D9: DATE RETURNED TO MANUFACTURER: SEP 19, 2022. SECTION H3: EVALUATED BY MANUFACTURER: YES. DEVICE EVALUATION: VISUAL INSPECTION UNDER MAGNIFICATION REVEALED THAT THE COMPLAINT LENS WAS RECEIVED CUT, BUT THE LENS WAS NOT CUT IN HALF. A DETACHED AND DAMAGED HAPTIC COULD ALSO BE OBSERVED. THE LENS WAS CLEANED AND, LENS DAMAGE AS WELL AS COSMETIC ISSUES, CONSISTENT WITH A LENS THAT WAS CRUSHED INSIDE OF THE LENS INSERT WERE OBSERVED AS WELL. THE COMPLAINT ISSUE OF DC-HAPTIC DAMAGED WAS IDENTIFIED DURING PRODUCT EVALUATION; HOWEVER, BASED ON THE COMPLAINT INVESTIGATION RESULTS THE COMPLAINT ISSUE COULD NOT BE CONFIRMED TO BE RELATED TO THE MANUFACTURING OR DESIGN PROCESS. THE OTHER OBSERVED ISSUES DURING THE PRODUCT EVALUATION COULD NOT BE CONFIRMED TO BE RELATED TO A MANUFACTURING OR DESIGN ISSUE. THEREFORE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY OR PRODUCT MALFUNCTION. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT UPON FULL INSERTION OF THE INTRAOCULAR LENS (IOL) INTO THE RIGHT EYE, THE HAPTIC BROKE. THERE WAS NO MEDICAL OR SURGICAL INTERVENTION REQUIRED. IT WAS UNKNOWN IF PROCEDURE COMPLETED SUCCESSFULLY USING THE SAME OR DIFFERENT LENS. PATIENT OUTCOME IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1574842 TECNIS IOL INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. ZA9003 05050474528833

    Patients

    Seq Age Sex Outcome Treatment
    1 Male