BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS IOL

    MDR report key: 13529388 · Received February 14, 2022

    Report

    Report Number
    3012236936-2022-00399
    Event Type
    Malfunction
    Date Received
    February 14, 2022
    Date of Event
    August 13, 2021
    Report Date
    April 6, 2022
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    UDI-DI
    05050474529045
    PMA / PMN Number
    P990080
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IF IMPLANTED, GIVE DATE: NOT APPLICABLE, AS LENS WAS REMOVED IN THE INITIAL SURGERY. IF EXPLANTED, GIVE DATE: NOT APPLICABLE, AS LENS WAS REMOVED IN THE INITIAL SURGERY. THE INTRAOCULAR LENS (IOL) HAS 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

    ADDITIONAL INFORMATION: SECTION D9: DEVICE AVAILABLE FOR EVALUATION: YES SECTION D9: RETURNED TO MANUFACTURER ON: FEB 14, 2022 SECTION H3: DEVICE EVALUATED BY MANUFACTURER: YES DEVICE EVALUATION: THE COMPLAINT LENS WAS RECEIVED LOOSE INSIDE THE ORIGINAL FOLDING CARTON. THE COMPLAINT ISSUE (COSMETIC ISSUES) COULD BE CONFIRMED, HOWEVER, IT MAY BE ATTRIBUTED TO HANDLING DURING IMPLANTATION AND CANNOT BE CONFIRMED TO BE RELATED TO A MANUFACTURING/ DESIGN ISSUE. ADDITIONAL CONDITIONS WERE OBSERVED (HAPTIC DAMAGE AND HAPTIC DETACHED); HOWEVER, THEY CANNOT BE CONFIRMED TO BE RELATED TO THE MANUFACTURING/ DESIGN PROCESS. CONCLUSION: AS A RESULT OF THE INVESTIGATION THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS INSERTED INTO PATIENT'S OPERATIVE EYE, HOWEVER, WAS REMOVED DURING THE SAME PROCEDURE AS THE LENS WAS SCRATCHED. THERE WAS NO PATIENT INJURY AND NO OTHER INTERVENTION WAS REQUIRED. THE PATIENT WAS DOING GOOD POST OPERATION. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    669464 TECNIS IOL INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. ZA9003 05050474529045

    Patients

    Seq Age Sex Outcome Treatment
    1 Male