Medical device manufacturer, Abbott Medical Optics (AMO), has issued a medical device safety alert concerning its Vitrectomy Cutter [Part number: NGP0025; lot numbers: CA06182].
The manufacturer has voluntarily initiated a recall of Vitrectomy Cutters because a possibility exists that, due to a packaging error, 20GA Vitrectomy Cutters may be found in a 25GA package and 25GA Vitrectomy Cutters may be found in a 20GA package. Use of a Vitrectomy Cutter that is a different size than expected could lead to the need to alter the surgical technique, including conjunctival dissection, incision enlargement and sclera sutures.
According to the manufacturer, two units of 20GA Vitrectomy Cutters in packaging labeled as 25GA
The affected users are advised to stop using and remove from the inventory all affected product. They can continue to use all other lots not affected by this recall.
According to the local supplier, the affected products are distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 21 April 2017