Medical device manufacturer, Abbott Medical Optics, has issued a medical device safety alert concerning its TECNIS 1-Piece Intraocular Lenses (IOLs). [Model: ZCB00; Diopter 24.5; Serial number: 4651021512].
The manufacturer has become aware of a small number of Tecnis IOLs that may have been mislabeled during the manufacturing process. The manufacturer is initiating this action due to detection of an inspection equipment malfunction that resulted in lenses not being fully checked prior to release. It has been identified that this malfunction may result in the release of mislabeled IOLs.
According to the manufacturer, use of a mislabeled IOL could lead to potential unexpected postoperative refractive error and may result in a secondary surgical intervention. The likelihood of any impact to the patients is very low.
Product recall is on-going.
According to the local supplier, the affected product is distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 2 September 2016