BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANTABLE COLLAMER LENS (ICL)

    MDR report key: 8903520 · Received August 16, 2019

    Report

    Report Number
    2023826-2019-01478
    Event Type
    Injury
    Date Received
    August 16, 2019
    Date of Event
    July 16, 2019
    Report Date
    July 18, 2019
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    MTA
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    PATIENT CODE 3191: PHOTOPHOBIA, PATIENT CODE 1791: CORNEAL OEDEMA, METHOD CODE 4117: LENS REMAINS IMPLANTED. CLAIM#: (B)(4).

    Additional Manufacturer Narrative · 1

    THIS PRODUCT IS NOT MARKETED IN THE US. (B)(4). NO SIMILAR COMPLAINT TYPE EVENTS WERE REPORTED FOR UNITS WITHIN THE SAME LOT. (B)(4).

    Description of Event or Problem · 1

    THE REPORTER INDICATED THAT A 13.2MM, VICMO13.2, -12.00 DIOPTER, IMPLANTABLE COLLAMER LENS WAS IMPLANTERD INTO THE PATIENTS RIGHT EYE (OD) ON (B)(6) 2019. EXCESSIVE VAULT, REFRACTIVE SURPRISE, ELEVATED IOP (INTRAOCULAR PRESSURE), SIGNIFICANT REDUCTION OF IRIDO-CORNEAL ANGLES AND BLURRED VISION WAS OBSERVED. ADDITION OF NEW PI (YAG) WAS REPORTED AS SECONDARY INTERVENTION. THE REPORTER STATED THAT THE PATIENT IS HAPPY WITH THE RESULTS AND DONT WANT TO CHANGE THE LENS . IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    694833 IMPLANTABLE COLLAMER LENS (ICL) PHAKIC INTRAOCULAR LENS MTA STAAR SURGICAL COMPANY VICMO 13.2 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention INJECTOR MODEL: MSI-PF, LOT # UNK