Alcon Research, Ltd. recalls Accurus 2500 Standalone Vitreous Probe REF 8065741018; Accurus 23 GA Standalone Vitreous Probe REF 8065750821; Accurus…

Recall date

June 2, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1940-2015

FDA classification

Class II

Brand / firm

Alcon Research, Ltd.

Sold / distributed

Worldwide Distribution-US (nationwide) and the countries of Argentina, Australia, Austria, Brazil, Canada, Chile, China, Colombia, Czech Republic, France, Germany, Hong Kong, Hungary, India, International APL, Italy, Japan, Kenya, Korea, Kosovo, Malaysia, Mexico, Morocco, Netherlands, New Zealand,…

Why it was recalled

Insufficient seal on the outside packaging, potentially affecting the sterility of the product.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Accurus 2500 Standalone Vitreous Probe REF 8065741018; Accurus 23 GA Standalone Vitreous Probe REF 8065750821; Accurus 25+ 2500 CPM Standalone Vitreous Probe REF 8065751122; Anterior Accurus Probe with Infusion Needle REF 8065803650; Single Use Sterile Probes Rx only. Intended to provide the surgeon with a single-use probe for performing vitrectomy surgical procedures while using the Alcon Accurus vitrectomy console.