BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS IOL

    MDR report key: 11648700 · Received April 12, 2021

    Report

    Report Number
    2648035-2021-07514
    Event Type
    Malfunction
    Date Received
    April 12, 2021
    Date of Event
    January 18, 2021
    Report Date
    September 22, 2022
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    UDI-DI
    05050474528956
    PMA / PMN Number
    P990080
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: SECTION H6: AS PART OF AN INTERNAL REVIEW OF OUR MDRS IT WAS IDENTIFIED THAT THE CODE 2199 PROVIDED ON THE INITIAL REPORT NEEDS TO BE CORRECTED. THIS CODE SHOULD NOT HAVE BEEN INDICATED IN THAT SECTION. HOWEVER, INFORMATION WAS MISSED IN THE INITIAL REPORT THAT THERE WAS MINOR DELAY IN TREATMENT BUT NO INDICATION OF CLINICAL SIGNIFICANCE ON OUTCOME. FIELD BELOW UPDATED: SECTION H6: HEALTH EFFECT IMPACT CODE: 4632 (CAPTURES MINOR DELAY IN TREATMENT). ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: UPON FURTHER REVIEW, IT WAS DISCOVERED THAT PATIENT DATE OF BIRTH, PRODUCT EXPIRATION DATE, AND PRODUCT MANUFACTURE DATE WERE INADVERTENTLY NOT INCLUDED IN THE INITIAL MDR. THEREFORE, THE FOLLOWING FIELDS HAVE BEEN UPDATED ACCORDINGLY IN THIS SUPPLEMENTAL REPORT: SECTION A2: DATE OF BIRTH: (B)(6) 1960. SECTION D4: EXPIRATION DATE: JUNE 10, 2025. SECTION H4: DEVICE MANUFACTURE DATE: JUNE 10, 2020. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    SECTION D9. DEVICE AVAILABLE FOR EVALUATION? YES RETURNED TO MANUFACTURER ON: 5/6/2021. 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. ONE HAPTIC WAS OBSERVED TO BE DAMAGED (BENT) AND THE OTHER HAPTIC WAS OBSERVED TO BE DETACHED BOTH CAN BE ATTRIBUTED TO HANDLING AND CANNOT BE CONFIRMED TO BE RELATED TO MANUFACTURING. BASED ON THE RETURN CONDITION OF THE LENS, NO FURTHER PRODUCT EVALUATION COULD BE PERFORMED. THE COMPLAINT ISSUE CAN BE BE CONFIRMED HOWEVER, IT CAN BE ATTRIBUTED TO HANDLING AND CANNOT BE CONFIRMED TO BE RELATED TO MANUFACTURING THEREFORE, 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 · 1

    AGE OR DATE OF BIRTH, WEIGHT, AND ETHNICITY: UNKNOWN/ NOT PROVIDED. IF IMPLANTED, GIVE DATE: NOT APPLICABLE, AS LENS WAS REMOVED/REPLACED DURING THE SAME PROCEDURE. IF EXPLANTED, GIVE DATE: NOT APPLICABLE, AS LENS WAS REMOVED/REPLACED DURING THE SAME PROCEDURE. 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 NOTICED TO HAVE THE HAPTIC RIPPED AFTER IT WAS INSERTED INTO THE EYE. THE IOL WAS TAKEN OUT AND A NEW IOL WAS PUT IN. THERE WAS NO VITRECTOMY OR SUTURES DONE. NO OTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    546757 TECNIS IOL INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. ZA9003 05050474528956

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown