Healon EndoCoat Ophthalmic Viscosurgical Device 의 안전성 경고

Safety alert

2014-11-19

2014-11-19

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20141119.html

Medical device safety alert: abbott medical optics healon endocoat ophthalmic viscosurgical device medical device manufacturer, abbott medical optics (amo) inc., has issued an advisory notice concerning the healon endocoat ophthalmic viscosurgical device (ovd) with the product number vt585. the advisory notice intends to re-emphasize proper techniques for the use of the syringe included in the healon endocoat directions for use (dfu). it provides an additional diagram regarding recommended syringe orientation to avoid finger grip dislodgement. the manufacturer has received complaints where the finger grip dislodged while depressing the syringe plunger. the finger grip dislodgement could result in the surgeon’s hand unintentionally moving the cannula further than intended, resulting in potential trauma to the eye. failure to follow the dfu can result in the finger grip becoming detached. specifically, the cannula should be fastened securely to the syringe: however, over tightening may cause the hub to weaken and possibly detach from the syringe. extrusion of a test drop is recommended prior to entering the eye, and excessive force on the plunger should be avoided. the manufacturer advises users to consult the dfu that is distributed with each device, which contains important warnings, and precautions for use of the product. according to the manufacturer, the affected products were distributed in hong kong. if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 19 november 2014.