BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSAR IOL

    MDR report key: 11610214 · Received April 2, 2021

    Report

    Report Number
    2648035-2021-07494
    Event Type
    Malfunction
    Date Received
    April 2, 2021
    Report Date
    September 22, 2022
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    UDI-DI
    05050474501867
    PMA / PMN Number
    P980040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: SECTION H6: AS PART OF AN INTERNAL REVIEW OF OUR MDRS IT WAS IDENTIFIED THAT THE IMPACT CODE 2199 NO HEALTH CONSEQUENCES OR IMPACT PROVIDED ON THE INITIAL REPORT NEEDS TO BE CORRECTED. IMPACT CODE 2199 NO LONGER APPLICABLE. THE CORRECT IMPACT CODE IS 4632 DELAY IN TREATMENT. THE FOLLOWING SECTION HAS BEEN UPDATED ACCORDINGLY: SECTION H6: HEALTH EFFECT - IMPACT CODE: 4632 DELAY IN TREATMENT. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    SECTION D. DEVICE AVAILABLE FOR EVALUATION? YES RETURNED TO MANUFACTURER ON: 4/26/2021 SECTION H3. DEVICE EVALUATED BY MANUFACTURER? YES DEVICE EVALUATION: VISUAL INSPECTION UNDER MAGNIFICATION REVEALED VISCOELASTIC RESIDUE ON THE OPTIC BODY AND HAPTICS, WHICH IS CONSISTENT WITH A LENS THAT WAS HANDLED DURING INSERTION. THE LENS WAS CLEANED AND HAPTIC DAMAGE AND LENS DAMAGE WERE OBSERVED, WHICH CAN BOTH BE ATTRIBUTED TO HANDLING AND RECEIVING THE LENS CRUSHED IN THE LENS INSERT AND CANNOT BE CONFIRMED TO BE RELATED TO MANUFACTURING. NO PRODUCT DEFICIENCY COULD BE IDENTIFIED. MANUFACTURING RECORD EVALUATION: BASED ON THE MANUFACTURING RECORDS REVIEW, AND HISTORICAL COMPLAINT REVIEW, THERE IS NO INDICATION OF A PRODUCT MALFUNCTION OR PRODUCT QUALITY DEFICIENCY. NO NONCONFORMITY REPORT, DOCUMENTATION OR LABELING CHANGES, AND ESCALATIONS ARE REQUIRED. A SEARCH REVEALED THAT NO OTHER COMPLAINTS WERE RECEIVED FROM THIS PRODUCTION ORDER. CONCLUSION: BASED ON THE INFORMATION OBTAINED, PRODUCT MALFUNCTION AND PRODUCT DEFICIENCY CANNOT BE CONFIRMED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED

    Additional Manufacturer Narrative · 1

    IMPLANT DATE: NOT APPLICABLE, AS LENS WAS NOT IMPLANTED. EXPLANT DATE: NOT APPLICABLE, AS LENS WAS NOT EXPLANTED. INITIAL REPORTER TELEPHONE NUMBER: (B)(6). AN ATTEMPT HAS BEEN MADE TO OBTAIN MISSING INFORMATION; HOWEVER, TO DATE, NO RESPONSE HAS BEEN RECEIVED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS FOLDING ISSUE WITH THE LEADING HAPTIC. IMPLANTATION WAS HALTED (DELAYED) BECAUSE INTRAOCULAR LENS (IOL) RETRACTED FROM THE EYE BUT IOL WAS NOT FULLY IMPLANTED. THE IOL CHECKED UNDER MICROSCOPE AND LEADING HAPTIC OUT OF SHAPE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    508659 SENSAR IOL INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. AR40E 05050474501867

    Patients

    Seq Age Sex Outcome Treatment
    1 Female