BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS IOL

    MDR report key: 18698421 · Received February 13, 2024

    Report

    Report Number
    3012236936-2024-00262
    Event Type
    Injury
    Date Received
    February 13, 2024
    Date of Event
    October 20, 2023
    Report Date
    June 18, 2024
    Manufacturer
    AMO MANUFACTURING NETHERLANDS
    Product Code
    MFK
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: UPON FURTHER REVIEW IT WAS NOTED THAT "G4" FIELD FOR THE PMA NUMBER WAS INADVERTENTLY POPULATED WITH P980040 ON THE INITIAL MDR; THE FIELD SHOULD HAVE BEEN LEFT BLANK. THEREFORE, THE INFORMATION IS BEING CORRECTED IN THIS SUPPLEMENTAL MDR REPORT AS PER THE FOLLOWING: SECTION G4: PMA/510(K) NUMBER: THIS REPORT IS BEING FILED ON AN INTERNATIONAL DEVICE; TECNIS OPTIBLUE PRELOADED 1-PIECE IOL, MODEL DCB00V THAT HAS A SIMILAR DEVICE, TECNIS SIMPLICITY PRELOADED 1-PIECE IOL MODEL DCB00 WHICH IS DISTRIBUTED IN THE UNITES STATES UNDER PMA P980040.. ADDITIONAL INFORMATION: SECTION D9 - DEVICE AVAILABLE FOR EVALUATION? YES. SECTION D9 - DATE RETURNED TO MANUFACTURER: MAY 15, 2024. SECTION H3 - DEVICE EVALUATED BY MANUFACTURER? YES. DEVICE EVALUATION: VISUAL INSPECTION WAS PERFORMED ON THE SUSPECT PRODUCT. THE LENS AND THE HAPTIC WERE FOUND CUT, HALF OF THE LENS WAS MISSING. THE LENS WAS CLEANED AND PRESENTED WITH NO ISSUES THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE COMPLAINT EVENT. NO FURTHER EVALUATION WAS PERFORMED. THE COMPLAINT ISSUE "UNEXPECTED POSTOP REFRACTION" AND "SECONDARY SURGICAL INTERVENTION" WERE NOT IDENTIFIED DURING PRODUCT EVALUATION. THE OTHER OBSERVED ISSUES DURING THE PRODUCT EVALUATION COULD NOT BE CONFIRMED TO BE RELATED TO THE MANUFACTURING OR DESIGN PROCESS. CONCLUSION: AS A RESULT OF THE INVESTIGATION, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    SECTION A2, A4 AND A5: PER REGULATION EU 2016/679 (GENERAL DATA PROTECTION REGULATION), PATIENT IDENTIFIERS WERE NOT COLLECTED OR RECORDED AND THEREFORE ARE NOT AVAILABLE. SECTION D6B - EXPLANT DATE: NOT APPLICABLE, LENS REMAINS IMPLANTED. SECTION E1 - TELEPHONE NUMBER: (B)(6). SECTION H3 - OTHER (81): THE INTRAOCULAR LENS (IOL) WAS NOT RETURNED FOR EVALUATION AS IT REMAINS IMPLANTED. THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT 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 AND POSSIBLE PRODUCT RETURN AND EVALUATION, IF THERE IS ANY FURTHER RELEVANT INFORMATION A SUPPLEMENTAL MEDWATCH WILL BE FILED. ATTEMPTS HAVE BEEN MADE TO OBTAIN FURTHER INFORMATION. HOWEVER, TO DATE, NO RESPONSE HAS BEEN RECEIVED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER IMPLANTATION OF TWO INTRAOCULAR LENSES (IOL) THE VISUAL ACUITY WAS ONLY AT 0.5 DIOPTER (D) AT ALL DISTANCES FOR OVER A YEAR WITH A RESIDUAL REFRACTION OF +0.75 D. THIS HAS ALREADY BEEN COMPENSATED WITH AN ADD ON IOL BUT HAS NOT SHOWN THE DESIRED OUTCOME. LENSES AND ADD ON ARE TO BE EXPLANTED, BUT THE DATE OF SURGERY IS STILL UNKNOWN. NO FURTHER DETAILS PROVIDED. A SEPARATE REPORT IS BEING SUBMITTED FOR THE OTHER IOL MENTIONED. THIS IS REPORT 1 OF 2.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1390054 TECNIS IOL LENS, MULTIFOCAL INTRAOCULAR MFK AMO MANUFACTURING NETHERLANDS DFR00V

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown