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.
FDA Recall Z-1940-2015 · Posted 2015-06-29
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Recalling FirmAlcon Research, Ltd.
Recall StatusTerminated
Product CodeHQC
Date Initiated2015-06-02
Date Terminated2017-04-20
Product Quantity35,475 units
Reason for Recall
Insufficient seal on the outside packaging, potentially affecting the sterility of the product.
Firm Action
Recall notification letters were sent to consignees on June 2, 2015.
Root Cause
Packaging
Distribution Pattern
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, Poland, Russia, Spain, Sri Lanka, Switzerland, Taiwan, Thailand, Turkey, and United Kingdom.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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