BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KS-3AI

    MDR report key: 9781508 · Received March 3, 2020

    Report

    Report Number
    2023826-2020-00422
    Event Type
    Injury
    Date Received
    March 3, 2020
    Date of Event
    January 31, 2020
    Report Date
    February 10, 2020
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    HQL
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: H3 - DEVICE EVALUATION: FTIR MICROSCOPES AND SEM-XMA WAS PERFORMED BY OUTSIDE LABORATORY. FTIR MICROSCOPES: THE ABSORPTION BAND OF THE SPECTRUM MAINLY CONSISTS OF GROUPS SUCH AS CH BOND (ALIPHATIC CH2, CH3), C = O BOND (ESTER), C-O BOND, SI-O BOND (SILICONE TYPE), AND P= O BOND (PHOSPHATE TYPE). IT IS CONSIDERED THAT AN ORGANIC COMPOUND HAVING A GROUP WITH MAIN COMPONENTS OF HIGHER FATTY ACID ESTERS AND PHOSPHATE ESTERS. SEM-XMA: XMA SPECTRUM SHOWS THE SAME COMPONENTS (-CARBON, O-OXYGEN, P-PHOSPHORUS, SI-SILICON, CA-CALCIUM) THAT ARE REPORTED IN LITERATURE" A CASE OF ASTROCYTOSIS WITH CALCIFICATION OF SILICONE INTRAOCULAR LENS" ISSUED IN THE PAST. REPORT CONCLUSION: AS HIGHER FATTY ACIDS, CALCIUM PHOSPHATE, ETC. WERE CONFIRMED AS THE COMPONENTS OF THE ADHERENT, IT IS ASSUMED THAT COMPONENTS IN THE EYES (AQUEOUS HUMOR AND VITREOUS CAVITY) HAD ADHERED ON THE LENS OF OPTICAL PART. AS THE PATIENT HAS STELLATE VITREOUS AND MUCH ADHERENT FOUND ON THE BACK SIDE OF THE LENS, IT IS POSSIBLE THAT SECONDARY CALCIFICATION HAS DEVELOPED. SINCE SIMILAR EVENTS WERE REPORTED IN OTHER LENSES FROM DIFFERENT MANUFACTURERS, WE ASSUME THAT VARIOUS FACTORS SPECIFIC TO THE PATIENT, SUCH AS VARIOUS COMPONENTS AND CONCENTRATIONS IN THE EYE CAUSED THE ISSUE, RATHER THAN SPECIFIC MATERIAL OF THE LENS OR MANUFACTURING PROCESSES. CLAIM# 430909

    Additional Manufacturer Narrative · 1

    (B)(4). THIS PRODUCT IS NOT MARKETED IN THE US. (B)(4).

    Description of Event or Problem · 1

    THE REPORTER INDICATED THAT A KS-3AI AQ310AI, INTRAOCULAR LENS WAS IMPLANTED INTO PATIENT'S LEFT EYE (OS). PATIENT REPORTED VISUAL ACUITY ISSUE. THE LENS WAS OBSERVED TO BE CLOUDY. THE LENS WAS REMOVED AND REPLACED WITH A 3-PIECE LENS (KOWA AM6KA) ON (B)(6) 2020. REPORTEDLY WHEN PATIENT VISITED THE HOSPITAL, POSTERIOR CUSPULE INCISION WAS MADE DUE TO STELLATE VITREOUS. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    242502 KS-3AI INTRAOCULAR LENS HQL STAAR SURGICAL COMPANY KS-3AI N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention UNK.