Events

Recall of nanoPOINT Injector System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Medicel Ag.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    65908
  • Event Risk Class
    Class 2
  • Event Number
    Z-1984-2013
  • Event Initiated Date
    2013-08-05
  • Event Date Posted
    2013-08-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-03-11
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=120811
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    intraocular lens - Product Code HQL
  • 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.
  • Action
    Medicel AG sent recall notification to its one direct consignee via email on 08/05/2013. The recall notification letter was titled "URGENT-Medical Device Correction Notice for nanoPOINT Injectors LOT 121402". The recall notification letter informed the customer of the product device description and lot number recalled, reason for recall, instructions to "not use this affected lot...and return them", contact information and an area on the bottom of the letter to acknowledge receipt of the correction notice. The firm's direct consignee who further distributed this product to the end users will send out notifications.

Device

nanoPOINT Injector System
  • Model / Serial
    Item number 37-0000-08  Lot number of the recalled products: LOT121402
  • Product Classification
    Ophthalmic Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution.
  • Product 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.
  • Manufacturer
    Medicel Ag

Manufacturer

Medicel Ag
  • Manufacturer Address
    Medicel Ag, Luchton 1262, Wolfhalden Switzerland
  • Manufacturer Parent Company (2017)
    Halma Plc
  • Source
    USFDA