BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WHITESTAR SIGNATURE CONSOLE

    MDR report key: 12234822 · Received July 27, 2021

    Report

    Report Number
    3006695864-2021-08139
    Event Type
    Injury
    Date Received
    July 27, 2021
    Date of Event
    February 5, 2019
    Report Date
    July 27, 2021
    Manufacturer
    AMO MANUFACTURING USA, LLC
    Product Code
    HQC
    PMA / PMN Number
    K060366
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE SERIAL NUMBER FOR THE DEVICE IS NOT AVAILABLE; THEREFORE, NO FURTHER INVESTIGATION CAN BE PERFORMED. IF THERE IS ANY FURTHER RELEVANT INFORMATION RECEIVED, A SUPPLEMENTAL MEDWATCH WILL BE FILED. CITATION: VAZQUEZ-FERREIRO, P., CARRERA-HUESO, F. J., BARREIRO-RODRIGUEZ, L., DIAZ-REY, M., & JORNET, J. E. (2019). PREVALENCE OF CATARACT COMPLICATIONS IN PATIENTS WITH PSEUDOEXFOLIATION SYNDROME IN NORTHWESTERN SPAIN. ARQUIVOS BRASILEIROS DE OFTALMOLOGIA, 82(6). ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    THE FOLLOWING ARTICLE WAS RECEIVED BASED ON A LITERATURE REVIEW: ARTICLE: PREVALENCE OF CATARACT COMPLICATIONS IN PATIENTS WITH PSEUDOEXFOLIATION SYNDROME IN NORTHWESTERN SPAIN. A RETROSPECTIVE COHORT STUDY WAS DONE TO ASSESS THE RELATIONSHIP BETWEEN PSEUDOEXFOLIATION SYNDROME (PES) AND THE INCIDENCE OF COMPLICATIONS AND ITS RELATED CLINICAL FACTORS IN PATIENTS UNDERGOING CATARACT SURGERY. A TOTAL OF 681 EYES OF 503 PATIENTS UNDERWENT CATARACT SURGERY AND WERE DIVIDED INTO TWO GROUPS: PATIENTS WITH PES (N=120 EYES OF 106 PATIENTS; PES GROUP) AND PATIENTS WITH NO PES (N= 561 EYES OF 487 PATIENTS; NON-PES GROUP). ALL PATIENT UNDERWENT BIMANUAL PHACOEMULSIFICATION WITH A TEMPORAL 2.75-MM LIMBAL INCISION USING THE DIVIDE AND CONQUER APPROACH WITH THE WHITESTAR SIGNATURE PHACO MACHINE (ADVANCED MEDICAL OPTICS, INC.). IN THE PES GROUP, INTRAOPERATIVE COMPLICATIONS INCLUDE POSTERIOR CAPSULAR RUPTURE (N=6), VITREOUS LOSS (N=2), ZONULAR DIALYSIS (N=7), AND INTRAOPERATIVE MIOSIS (N=13) IN THE NON-PES GROUP, INTRAOPERATIVE COMPLICATIONS INCLUDE POSTERIOR CAPSULAR RUPTURE (N=28), VITREOUS LOSS (N=11), ZONULAR DIALYSIS (N=5), AND INTRAOPERATIVE MIOSIS (N=30) WHILE EARLY POSTOPERATIVE COMPLICATIONS (WITHIN 1 YEAR) INCLUDE RETINAL DETACHMENT (N=8), SUPRACHOROIDAL HEMORRHAGE (N=2), AND ENDOPHTHALMITIS (N=3). THERE ARE NO INDICATIONS IN THE ARTICLE OF ANY INTERVENTIONS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1129659 WHITESTAR SIGNATURE CONSOLE PHACOEMULSIFICATION SYSTEM HQC AMO MANUFACTURING USA, LLC NGP680300

    Patients

    Seq Age Sex Outcome Treatment
    1 Other