BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS SIMPLICITY

    MDR report key: 14164237 · Received April 20, 2022

    Report

    Report Number
    3012236936-2022-00956
    Event Type
    Malfunction
    Date Received
    April 20, 2022
    Date of Event
    March 24, 2022
    Report Date
    June 7, 2022
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    UDI-DI
    05050474739437
    PMA / PMN Number
    P980040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: IN REVIEW, IT WAS NOTED THAT THE SECTION "G4" OF THE INITIAL MDR REPORT WAS INADVERTENTLY POPULATED WITH THE PMA# P980040 WHICH IS INCORRECT. THE "G4" FIELD SHOULD HAVE BEEN KEPT EMPTY AND THE JUSTIFICATION FOR THAT SHOULD HAVE BEEN CAPTURED TO THE SECTION "H10" OF THE INITIAL MDR REPORT. THE INFORMATION HAS BEEN CORRECTED IN THIS SUPPLEMENTAL MDR REPORT AND THE FOLLOWING FIELD WAS UPDATED ACCORDINGLY: SECTION G4: THIS REPORT IS BEING FILED ON AN INTERNATIONAL DEVICE; TECNIS EYHANCE OPTIBLUE SIMPLICITY, MODEL DIB00V THAT HAS A SIMILAR DEVICE, TECNIS SIMPLICITY TECNIS EYHANCE IOL MODEL DIB00 WHICH IS DISTRIBUTED IN THE UNITES STATES UNDER PMA P980040. ADDITIONAL INFORMATION: SECTION D9: DEVICE AVAILABLE FOR EVALUATION? YES. SECTION D9: RETURNED TO MANUFACTURER: YES. SECTION D9: DATE RETURNED TO MANUFACTURER: APR 20, 2022. SECTION H3: DEVICE EVALUATED BY MANUFACTURER: YES. DEVICE EVALUATION: VISUAL INSPECTION UNDER MAGNIFICATION REVEALED THAT THE LENS WAS RECEIVED COATED IN VISCOELASTIC RESIDUE. THE LENS WAS CLEANED AND, LENS DAMAGE WAS OBSERVED. TO FURTHER INVESTIGATE THE ROOT CAUSE, THE HANDPIECE IS REQUIRED FOR EVALUATION; HOWEVER, NO HANDPIECE WAS RECEIVED AS PART OF THIS RETURN THEREFORE, NO PRODUCT EVALUATION COULD BE PERFORMED ON THE HANDPIECE. MANUFACTURING RECORD REVIEW: THE MANUFACTURING RECORDS REVIEW WAS PERFORMED, AND NO NONCONFORMITY REPORT WAS FOUND AS PART OF THIS MANUFACTURING RECORDS REVIEW. THE PRODUCT WAS MANUFACTURED ACCORDING TO SPECIFICATIONS. THE SEARCH REVEALED THAT NO OTHER COMPLAINTS FOR THIS PRODUCTION ORDER NUMBER HAVE BEEN RECEIVED. CONCLUSION: AS A RESULT OF THE INVESTIGATION THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY AND THE REPORTED ISSUE COULD NOT BE CONFIRMED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    WEIGHT: UNKNOWN, INFORMATION NOT PROVIDED. IF IMPLANTED, GIVE DATE: NOT APPLICABLE, AS LENS WAS REMOVED/REPLACED IN THE INITIAL SURGERY. IF EXPLANTED, GIVE DATE: NOT APPLICABLE, AS LENS WAS REMOVED/REPLACED IN THE INITIAL SURGERY. EMAIL ADDRESS :UNKNOWN/NOT PROVIDED. TELEPHONE NUMBER: (B)(6). (B)(4). ATTEMPTS HAVE BEEN MADE TO OBTAIN THE 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 · 0

    IT WAS REPORTED THAT THE SURGEON OBSERVED A SHINING EDGE ON A PRELOADED INTRAOCULAR LENS (IOL) POST IMPLANTATION. A CLOSER LOOK REVEALED THAT THE LENS HAD A CRACK. THE IOL WAS REMOVED AS SURGEON SUSPECTED THE ISSUE MIGHT DEVELOP POSTOPERATIVE GLARE. THE SAME MODEL LENS WITH SAME DIOPTER POWER WAS PLACED AS THE REPLACEMENT IOL. ACCOUNT PROVIDED THAT THE INCISION WAS ENLARGED TO ABOUT 6 MILLIMETERS (MM) AND THE IOL WAS REMOVED WHOLE. NO PATIENT INJURY WAS REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1769442 TECNIS SIMPLICITY INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. DIB00V 05050474739437

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Male