Important Safety Alerts

Important Safety Alerts

Medical Device Safety Alert: Abbott Medical Optics Healon Ophthalmic Viscoelastic Devices

19 Apr 2017

Medical device manufacturer, Abbott Medical Optics (AMO), has issued a medical device safety alert concerning its Healon Ophthalmic Viscoelastic Devices (OVDs) [Model: HEALVON (0.85ML), lot number: UB32573; HEALVON GV (0.85ML); lot number: UB32576].

According to the manufacturer, certain Healon OVD solutions in the affected lots may contain microscopic glass particles due to damage that occurred at the cylinder neck during the manufacturing process. Use of OVD solutions with glass particles could potentially lead to intraocular injury.

The affected users are advised to stop using and remove from the inventory all affected OVD lots. 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 19 April 2017

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