BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPLANTABLE COLLAMER LENS (ICL)

    MDR report key: 11662621 · Received April 13, 2021

    Report

    Report Number
    2023826-2021-01048
    Event Type
    Malfunction
    Date Received
    April 13, 2021
    Report Date
    March 24, 2021
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    MTA
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B5: PER UPDATED INFORMATION " THE PATIENT IS NOTICING AN IMPROVEMENT IN THEIR SYMPTOMS AND IS HOLDING OFF ON MAKING A DECISION UNTIL WINTER." CLAIM # (B)(4).

    Additional Manufacturer Narrative · 0

    H6: DEVICE HISTORY RECORD (OHR) REVIEW: BASED ON THE RESULTS OF THE INVESTIGATION, ALL RELEASED DEVICES FROM THE ASSOCIATED WORK ORDER(S), INCLUDING THE SUSPECTED DEVICE; HAVE BEEN MANUFACTURED WITHIN ESTABLISHED PROCESS PARAMETERS; AND THERE IS NO INDICATION THAT THE MANUFACTURING AND PROCESSING OF THE DEVICE CONTRIBUTED TO THE COMPLAINT ISSUE. CLAIM# (B)(4).

    Additional Manufacturer Narrative · 1

    THIS PRODUCT IS NOT MARKETED IN THE US. ONE SIMILAR COMPLAINT TYPE EVENTS FOUND WITHIN THE ASSOCIATED LOT. (B)(4).

    Description of Event or Problem · 1

    THE REPORTER INDICATED THAT A 13.2MM, VICM5_13.2, -6.00 DIOPTER, IMPLANTABLE COLLAMER LENS WAS IMPLANTED INTO THE PATIENTS LEFT EYE (OS) ON (B)(6) 2020. THE REPORTER STATED " HE IS COMPLAINING OF HALOS/GLARES AND THEN A REFRACTIVE SURPRISE." IT WAS LATER REPORTED THAT THE PATIENT IS ALSO EXPERIENCING BLURRED VISION, CIRCLES IN VISION AND RAINBOW HALOES. LENS REMAINS IMPLANTED. THE REPORTER STATED " I BELIEVE HE IS GOING TO WAIT A COUPLE OF MONTHS AND SEE IF HE CAN ADAPT TO THE LENSES." IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    559240 IMPLANTABLE COLLAMER LENS (ICL) PHAKIC INTRAOCULAR LENS MTA STAAR SURGICAL COMPANY VICM5 13.2 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Male CARTRIDGE MODEL: SFC-45 W/FTP, LOT# 1459824| INJECTOR MODEL: MSI-PF, LOT# 1495447