Aaren Scientific, Incorporated Recalls
Showing 1-2 of 2 recalls
Intraocular Lens (IOL), Part No. EC-3 PAL, Diopter: 17.5, 18.0, 18.5, 19.0, 19.5, 21.5, 23.5, 9.0, 22.5, 23.0, 21.0, 24.0. The device is indicated for primary implantation in the capsular bag of the eye for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed. Aaren Scientifics EC-3 IOLs are intended for primary implantation in the capsular bag of the eye for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed
Aaren Scientific is recalling intraocular lenses because the instructions for use (IFU) are not fully compliant with US requirements.
A customer notification letter dated 2/13/15 was sent to all customers who received the Intraocular Lens model EC-3 PAL. The letter provides the customers with the problems identified and the actions to be taken. Customers are instructed to confirm receipt of the recall letter and to contact Mark Scheib at (909) 906-5119 or via email at mark.scheib@zeiss.com with any questions or comments.
Intraocular Lens (IOL). Model: EC-3, Serial Number: 1169371106, 1169401106, 1169471106 The device is indicated for primary implantation in the capsular bag of the eye for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed.
The recall was initiated because Aaren Scientific has confirmed that a specific group of lenses were shipped without a complete expiry date showing on the label.
Aaren Scientific sent a recall communication letter dated August 2, 2011, August 3, 2011, and August 30, 2011, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Aaren Scientific is requesting that you return the lenses and we will rework the product and return them back to you. Please let me know and I will issue an RGA number and inform you of our FedEx account number to reference. In the meantime, we are conducting an internal investigation regarding this issue. Once this has been closed out then we will notify you of our findings. For further questions please call (909) 937-1033 ext. 108.