BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANTABLE COLLAMER LENS (ICL)

    MDR report key: 17558373 · Received August 16, 2023

    Report

    Report Number
    2023826-2023-03544
    Event Type
    Injury
    Date Received
    August 16, 2023
    Report Date
    July 21, 2023
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    MTA
    PMA / PMN Number
    P030016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6- HEALTH EFFECT- CLINICAL CODE 4581: PIGMENT DEPOSITION ON THE ENDOTHELIUM, SHALLOW ANTERIOR CHAMBER, AND BOWING OF THE IRIS BILATERALLY. H6 - DEVICE CODE 1494: OFF-LABEL USE (UNDER 21YRS OF AGE AT DATE OF IMPLANT) CLAIM# (B)(4).

    Description of Event or Problem · 0

    AN ARTICLE WAS PUBLISHED IN THE AMERICAN JOURNAL OF CASE REPORTS TITLED, 'PRESUMED INDICATED IMPLANTATION OF POSTERIOR CHAMBER PHAKIC INTRAOCULAR LENS'. THE ARTICLE REPORTS " A 23-YEAR-OLD WOMAN WAS REFERRED FOR POOR VISION FOLLOWING AN IMPLANTATION OF BILATERAL TORIC IMPLANTABLE COLLAMER LENS (ICL) IMPLANTATION WHEN SHE WAS 18 YEARS OLD FOR HIGH MYOPIC ASTIGMATISM AND ANISOMETROPIA. ON PRESENTATION, THE BEST CORRECTED VISUAL ACUITY WAS 4-6/200 AND 2-3/200 IN THE RIGHT EYE AND LEFT EYE, RESPECTIVELY. SLIT LAMP EXAMINATION INDICATED A CLEAR CORNEA WITH PIGMENT DEPOSITION ON THE ENDOTHELIUM, HIGH ICL VAULT, SHALLOW ANTERIOR CHAMBER, AND BOWING OF THE IRIS BILATERALLY. THE PATIENT UNDERWENT BILATERAL REMOVAL OF THE ICLS ON SEPARATE VISITS, YET THE VISION REMAINED UNCHANGED. DIAGNOSTICS REVEALED THAT THE PATIENT HAD BULL'S EYE MACULOPATHY WITH ATROPHY DUE TO HER CONE-ROD DYSTROPHY, WHICH CAUSED THE POOR VISION". THE REPORT EMPHASIZES THE NEED FOR CAREFUL AND APPROPRIATE PATIENT AND INTRAOCULAR SIZE SELECTION FOR REFRACTIVE SURGERY. IT INDICATES THE IMPORTANCE OF THOROUGH MEDICAL EXAMINATION, INCLUDING GENETIC TESTING, FUNDUS EXAMINATION, AND OPTICAL COHERENCE TOMOGRAPHY WHEN RETINAL DYSTROPHY IS SUSPECTED. GENERALLY, CLOSE FOLLOW-UP IS CRUCIAL IN THE SETTING OF HIGH VAULTING FOLLOWING ICL IMPLANTATION TO PREVENT SECONDARY COMPLICATIONS. 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
    458828 IMPLANTABLE COLLAMER LENS (ICL) PHAKIC INTRAOCULAR LENS MTA STAAR SURGICAL COMPANY N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention