BEUDAMED
    FDA Enforcement Class II Terminated

    Product Name: nanoPOINT Injector System, item number 37-0000-08. Intended to fold and insert a STAAR Surgical Collamer¿ nanoFLEX or Afinity IOLs, through surgical procedure in a human eye.

    Recall: Z-1984-2013 · Reported August 28, 2013

    Enforcement

    Recall Number
    Z-1984-2013
    Event ID
    65908
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Medicel Ag
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    August 28, 2013
    Initiation Date
    August 5, 2013
    Classification Date
    August 20, 2013
    Termination Date
    March 11, 2014
    Address
    Luchton 1262, N/A, Wolfhalden, N/A, N/A, Switzerland

    Description

    Product Name: nanoPOINT Injector System, item number 37-0000-08. Intended to fold and insert a STAAR Surgical Collamer¿ nanoFLEX or Afinity IOLs, through surgical procedure in a human eye.

    Reason

    The firm initiated this recall of one lot (121402) of nanoPOINT Injectors after they noticed that Tyvek lids might have been damaged and, therefore, the stability of the sterile barrier might be negatively affected.

    Code Info

    Item number 37-0000-08 Lot number of the recalled products: LOT121402

    Distribution

    Nationwide Distribution.

    Quantity

    68 boxes or 680 units