Medical device manufacturer, Johnson & Johnson Vision, Inc., has issued a medical device safety alert concerning its Healon GV PRO Sodium Hyaluronate Ophthalmic Viscosurgical Devices [Model: Healon GV PRO 0.85 mL; Affected Lot Number in Hong Kong: UE31439].
The manufacturer has voluntarily recalling 21 lot of Healon GV Pro distributed from April to November 2019. The voluntary recall is being initiated due to complaints reporting that the affected product may be difficult to remove from the eye, leading to increased post-operative intra-ocular pressure with additional intervention.
According to the manufacturer, there have also been reports of potential clogging of phacoemulsification equipment tubing, which may lead to delay in the procedure or ocular injury.
Product recall is on-going.
According to the local supplier, only one affected lot is distributed in Hong Kong.
If you are in possession of the affected product, please contact your supplier for necessary actions.
Posted on 3 December 2019