BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK_PHACO MACHINE_WHITESTAR SIGNATURE SYSTEM

    MDR report key: 15255858 · Received August 18, 2022

    Report

    Report Number
    3012236936-2022-02222
    Event Type
    Injury
    Date Received
    August 18, 2022
    Date of Event
    December 14, 2021
    Report Date
    August 18, 2022
    Manufacturer
    AMO MANUFACTURING USA, LLC
    Product Code
    HQC
    PMA / PMN Number
    K060366
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION A - PATIENT DEMOGRAPHICS: SEVERAL ATTEMPTS TO COLLECT INFORMATION REGARDING PATIENT DEMOGRAPHICS HAVE BEEN MADE BUT AT THE TIME OF THIS REPORT NO INFORMATION HAS BEEN PROVIDED. THERE IS A SUMMARY OF THE AGE AND THE GENDER OF THE PATIENTS INVOLVED IN THE STUDY AND IT HAS BEEN PROVIDED BELOW. AGE AT SURGERY - 66 ± 9 YRS. MALE - 60 PATIENTS. FEMALE - 95 PATIENTS. (B)(4). DEVICE EVALUATION: THE DEVICE WAS NOT RETURNED FOR EVALUATION. SINCE SERIAL NUMBER IS UNKNOWN A MANUFACTURER RECORD REVIEW RELATED TO THE DEVICE INCLUDING DEVICE HISTORY RECORD COULD NOT BE PERFORMED. AS A RESULT OF THE INVESTIGATION THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY AND THE REPORTED ISSUE COULD NOT BE VERIFIED. CITATION: MOSHIRFAR M., WAITE AJ., ELLIS JH., HUYNH R., PLACIDE J., BARKE MR., MCCABE SE., RONQUILLO YC., HOOPES PC JR., BRADLEY MJ., HOOPES PC. (2021). A ONE YEAR LONGITUDINAL COMPARATIVE ANALYSIS OF VISUAL OUTCOMES BETWEEN FEMTOSECOND LASER-ASSISTED CATARACT SURGERY AND STANDARD PHACOEMULSIFICATION CATARACT SURGERY. CLIN OPHTHALMOL.15(1), PP.4667-4680. AN ATTEMPT HAS BEEN MADE TO OBTAIN MISSING INFORMATION; HOWEVER, NO DEFINITIVE RESPONSE HAS BEEN RECEIVED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    THE FOLLOWING ARTICLE WAS RECEIVED BASED ON LITERATURE REVIEW. ARTICLE: A ONE YEAR LONGITUDINAL COMPARATIVE ANALYSIS OF VISUAL OUTCOMES BETWEEN FEMTOSECOND LASER-ASSISTED CATARACT SURGERY AND STANDARD PHACOEMULSIFICATION CATARACT. A RETROSPECTIVE, SINGLE-CENTER COMPARATIVE STUDY WAS DONE TO ASSESS VISUAL OUTCOMES OVER TIME OF FEMTOSECOND LASER-ASSISTED CATARACT SURGERY (FLACS) COMPARED TO STANDARD PHACOEMULSIFICATION CATARACT SURGERY (PCS). A TOTAL OF 298 EYES WERE DIVIDED TO PCS GROUP (N=155EYES) AND FLACS GROUP (N=143 EYES) AND WERE ANALYZED AT 1 WEEK, 3 MONTHS, AND 1 YEAR. PATIENTS UNDERGOING FLACS WERE TREATED WITH THE CATALYS FEMTOSECOND LASER SYSTEM (PRECISION LENS, BLOOMINGTON, MN). PHACOEMULSIFICATION WAS PERFORMED IN A DIVIDE-AND- CONQUER FASHION USING THE WHITESTAR SIGNATURE PHACOEMULSIFICATION SYSTEM (ADVANCED MEDICAL OPTICS INC, INC. SANTA ANA, CA). IMPLANTED INTRAOCULAR LENSES (IOLS) WERE EITHER TORIC OR NON-TORIC. AMONG THESE INCLUDED IOLS FROM THE TECNIS PLATFORM (JOHNSON & JOHNSON) AND AMO (ABBOTT MEDICAL OPTICS): ZCB00, TECNIS MONOFOCAL 1-PIECE IOL (PCS [N=26 EYES]; FLACS [N=22 EYES]); ZA, TECNIS MONOFOCAL 3-PIECE IOL (FLACS [N=2 EYES]); ZCT/ZCU, TECNIS TORIC II IOL (PCS [N=21 EYES]; FLACS [N=26 EYES]); ZKU, TECNIS MULTIFOCAL TORIC II IOL (FLACS [N=3 EYES]); ZMA, TECNIS MULTIFOCAL IOL (PCS [N=1 EYE]); ZXR00, TECNIS SYMFONY IOL (PCS [N=5 EYES]; FLACS [N=2 EYES]); ZXT, AMO SYMFONY TORIC IOL (PCS [N=30 EYES]; FLACS [N=29 EYES]). THERE WERE OTHER IOLS USED FROM OTHER MANUFACTURERS. COMPLICATIONS INCLUDED: POSTOPERATIVE LOSS OF 1 LINE (CHANGE IN SNELLEN BDVA): PSC GROUP = 10% (N=5 EYES); FLACS GROUP = 2% (N=1 EYE). AT 3 MONTHS POSTOPERATIVE: GLARE: FLACS (N=1 EYE). HALO: PCS (N=3 EYES); FLACS (N=8 EYES). PHOTOPHOBIA: PCS (N=2 EYES). DRY EYES: PCS (N=6 EYES); FLACS (N=13 EYES). NIGHT VISION ISSUES: PCS (N=6 EYES); FLACS (N=3 EYES). AT 1 YEAR POSTOPERATIVE: DRY EYES: PCS (N=5 EYES); FLACS (N=11 EYES). POSTOPERATIVE PROCEDURES INCLUDED: YAG LASER CAPSULOTOMY (= 3 MONTHS POST-OP): PCS (N=1 EYE): FLACS (N=1 EYE). YAG LASER CAPSULOTOMY (= 1-YEAR POST-OP): PCS (N=5 EYES); FLACS (N=8 EYES). LIMBAL RELAXING INCISIONS: FLACS = (N=6 EYES). IT IS UNCLEAR HOWEVER, IF IT WERE OUR DEVICES OR THE OTHER DEVICES IN THE STUDY THAT WERE USED OR IMPLANTED IN THE EYE THAT CAUSED THESE EVENTS. THERE WERE NO FURTHER INTERVENTIONS REPORTED. THIS REPORT IS FOR THE WHITESTAR SIGNATURE SYSTEM USED FOR THE STANDARD PHACOEMULSIFICATION CATARACT PROCEDURE, MODEL UNKNOWN. SEPARATE REPORTS ARE BEING SUBMITTED FOR THE OTHER LISTED DEVICES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1848398 UNK_PHACO MACHINE_WHITESTAR SIGNATURE SYSTEM UNIT, PHACOFRAGMENTATION HQC AMO MANUFACTURING USA, LLC NGP680300

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention