Recall Z-1940-2015 ยท HQC Unit, Phacofragmentation
Alcon Research, Ltd.
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 Accuru
| Date | Jun 29, 2015 (initiated Jun 2, 2015) |
| Status | Terminated |
| Reason | Insufficient seal on the outside packaging, potentially affecting the sterility of the product. |
| Root cause | Packaging |
| Action | Recall notification letters were sent to consignees on June 2, 2015. |
| Quantity | 35,475 units |
| Distribution | 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, P |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K911808 | GEMINI OPHTHALMIC SURGERY SYSTEM Alcon Laboratories, Jun 25, 1991 |