BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WHITESTAR SIGNATURE PRO

    MDR report key: 17455524 · Received August 3, 2023

    Report

    Report Number
    3012236936-2023-01914
    Event Type
    Injury
    Date Received
    August 3, 2023
    Report Date
    November 20, 2023
    Manufacturer
    AMO MANUFACTURING USA, LLC
    Product Code
    HQC
    PMA / PMN Number
    K151636
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION A2: MEAN AGE 71.6 +- 10.5. SECTION A3: 14 FEMALE AND 13 MALE PATIENTS. SECTION B3: DATE OF EVENT: EXACT DATES NOT PROVIDED. ARTICLE ACCEPTANCE DATE IS JANUARY 8, 2023. THE STUDY WAS CONDUCTED FOR SURGERIES PERFORMED BETWEEN DECEMBER 2016 AND DECEMBER 2020. SECTION D4: SERIAL NUMBER: UNKNOWN, INFORMATION NOT PROVIDED. SECTION D4: EXPIRATION DATE: UNKNOWN, AS THE SERIAL NUMBER WAS NOT PROVIDED. SECTION D4: UDI NUMBER: UNKNOWN, AS THE SERIAL NUMBER WAS NOT PROVIDED. SECTION H3 - OTHER (81): THE MACHINE WAS NOT RETURNED FOR EVALUATION. 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. SECTION H4: DEVICE MANUFACTURE DATE: UNKNOWN, AS THE SERIAL NUMBER WAS NOT PROVIDED. CITATION: OKADA, N.; HIROOKA, K.; ONOE, H.; OKUMICHI, H.; KIUCHI, Y. COMPARISON OF MID-TERM OUTCOMES BETWEEN MICROHOOK AB INTERNO TRABECULOTOMY AND GONIOTOMY WITH THE KAHOOK DUAL BLADE. J. CLIN. MED. 2023, 12, 558. HTTPS://DOI.ORG/10.3390/JCM12020558. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    CORRECTED INFORMATION: BASED ON A FURTHER REVIEW OF THE INFORMATION RECEIVED, THE CODE 1875 (GLAUCOMA) WAS REMOVED AND THE CODE 4625 (ADDITIONAL SURGERY) WAS ADDED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    THE FOLLOWING ARTICLE WAS RECEIVED BASED ON A LITERATURE REVIEW: ARTICLE: COMPARISON OF MID-TERM OUTCOMES BETWEEN MICROHOOK AB INTERNO TRABECULOTOMY AND GONIOTOMY WITH THE KAHOOK DUAL BLADE A RETROSPECTIVE STUDY WAS DONE TO COMPARE THE MID-TERM SURGICAL OUTCOMES BETWEEN PATIENTS WHO UNDERWENT PHACOEMULSIFICATION IN PRIMARY OPEN-ANGLE GLAUCOMA (POAG) AND EXFOLIATION GLAUCOMA COMBINED WITH MICROHOOK AB INTERNO TRABECULOTOMY (LOT) AND GONIOTOMY WITH THE KAHOOK DUAL BLADE (KDB). A TOTAL OF 54 EYES UNDERWENT EITHER MICROHOOK AB INTERNO TRABECULOTOMY (LOT) (N=27 EYES) OR GONIOTOMY WITH THE KAHOOK DUAL BLADE (N=27 EYES). PHACOEMULSIFICATION IN ALL EYES WAS PERFORMED USING THE SIGNATURE PRO (JOHNSON & JOHNSON) AND THE INTRAOCULAR LENS (IOL) IMPLANTED WERE EITHER THE PCB00V (JOHNSON & JOHNSON) OR THE XY1 (HOYA) IOL. IN ORDER TO INCREASE THE VISUALITY OF SCHLEMM¿S CANAL AFTER THE CATARACT SURGERY, SUFFICIENT SODIUM HYALURONATE (HEALON; JOHNSON & JOHNSON VISION) WAS ADDED TO THE ANTERIOR CHAMBER. POSTOPERATIVE COMPLICATIONS INCLUDE TRANSIENT IOP ELEVATION (N=5) AND HYPHEMA WITH NIVEAU (N=4). THE HYPHEMA DISAPPEARED WITHIN 2 WEEKS IN ALL OF THE CASES. IT WAS REPORTED THAT ADDITIONAL SURGERY WAS REQUIRED IN 3 EYES IN THE KDB-PHACO GROUP, WITH ONE SURGERY FOR EXFOLIATION GLAUCOMA AND THE OTHER TWO SURGERIES FOR PRIMARY OPEN ANGLE GLAUCOMA (POAG) ALL OF WHICH WERE DUE TO INADEQUATE IOP REDUCTION (>21 MMHG). NO FURTHER DETAILS WERE PROVIDED. SEPARATE REPORTS WILL BE SUBMITTED FOR THE OTHER TWO JOHNSON & JOHNSON DEVICES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    960968 WHITESTAR SIGNATURE PRO UNIT, PHACOFRAGMENTATION HQC AMO MANUFACTURING USA, LLC NGP680301 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention