BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANTABLE COLLAMER LENS (ICL)

    MDR report key: 12102535 · Received July 1, 2021

    Report

    Report Number
    2023826-2021-02131
    Event Type
    Injury
    Date Received
    July 1, 2021
    Report Date
    June 7, 2021
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    QCB
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3- DEVICE EVALUATION: THE LENS WAS RETURNED IN A MICROCENTRIFUGE VIAL WITH MOISTURE. VISUAL INSPECTION FOUND THE HAPTIC TORN. DIMENSIONAL INSPECTION FOUND THE LENS TO BE WITHIN SPECIFICATIONS. CLAIM# (B)(4).

    Additional Manufacturer Narrative · 0

    B5- THE REPORTER INDICATED THAT A 12.6MM, VTICMO12.6, -15.50/4.0/092 (SPHERE/CYLINDER/AXIS), IMPLANTABLE COLLAMER LENS WAS IMPLANTED INTO THE PATIENT'S RIGHT EYE (OD) (B)(6) 2019. LENS ROTATION NOT ASSOCIATED TO A LOW VAULT, REFRACTIVE CHANGE OVERTIME AND POOR UNAIDED VISION WERE OBSERVED. LENS REMAINS IMPLANTED AND A LENS EXCHANGE IS PLANNED. TH REPORTER MARKED THE CAUSE OF THE EVENT AS UNKNOWN AND STATED "BASICALLY VISION AND TICL POSITION CHANGED AFTER 6/12 AND NOW OFF AXIS AND POOR UNAIDED VISION." ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED. CLAIM# (B)(4).

    Additional Manufacturer Narrative · 0

    B5- PER UPDATED CQ: THE REPORTER INDICATED THAT A 12.6MM, VTICMO12.6, -15.50/+4.0/092 (SPHERE/CYLINDER/AXIS), IMPLANTABLE COLLAMER LENS WAS IMPLANTED INTO THE PATIENT'S RIGHT EYE (OD) (B)(6) 2019. LOW VAULT WITH ROTATION, REFRACTIVE CHANGE OVERTIME AND POOR UNAIDED VISION WERE OBSERVED. LENS WAS EXPLANTED IN (B)(6) 2021 AND REPLACED WITH A LONGER LENGTH LENS WITH SIMILAR POWER (VTICMO 13.2, -15.50/+4.0/095) ON (B)(6) 2021. THE PROBLEM WAS RESOLVED AND "VAULT HAS IMPROVED AND PATIENT IS HAPPY". CAUSE OF EVENTS WAS REPORTED AS UNKNOWN. D6B- (B)(6) 2021. H6 DEVICE CODE: 1583 ADDED; LOW VAULT WITH LENS ROTATION REPORTED. H6 DEVICE CODE: 1494: OFF LABEL USE- AGE<21 YEARS OLD. CLAIM# (B)(4).

    Additional Manufacturer Narrative · 1

    IMPLANT DATE: (B)(6) 2019. THIS PRODUCT IS NOT MARKETED IN THE US. WORK ORDER SEARCH: NO SIMILAR COMPLAINT TYPE EVENTS WERE REPORTED FOR UNITS WITHIN THE SAME LOT. CLAIM# (B)(4).

    Description of Event or Problem · 1

    THE REPORTER INDICATED THAT A 12.6MM, VTICMO12.6, -15.50/4.0/092 (SPHERE/CYLINDER/AXIS), IMPLANTABLE COLLAMER LENS WAS IMPLANTED INTO THE PATIENT'S RIGHT EYE (OD) (B)(6) 2019. LENS ROTATION NOT ASSOCIATED TO A LOW VAULT AND REFRACTIVE CHANGE OVERTIME WERE OBSERVED. LENS REMAINS IMPLANTED. CAUSE OF THE EVENT IS REPORTED AS DEVICE, "CHANGED POSITION AND NOW OFF AXIS AND POOR UNAIDED VISION. " 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
    1000680 IMPLANTABLE COLLAMER LENS (ICL) PHAKIC TORIC INTRAOCULAR LENS QCB STAAR SURGICAL COMPANY VTICMO12.6 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention