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Class 2 Device Recall Alcon Accurus Standalone Vitreous Probe Paks |
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| Date Initiated by Firm |
June 02, 2015 |
| Date Posted |
June 29, 2015 |
| Recall Status1 |
Terminated 3 on April 20, 2017 |
| Recall Number |
Z-1940-2015 |
| Recall Event ID |
71383 |
| 510(K)Number |
K911808
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| Product Classification |
Unit, phacofragmentation - Product Code HQC
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| Product |
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. |
| Code Information |
Accurus 23 GA Standalone Vitreous Probe: Lot Number: 14010428X, Expiration Date: 1/14/2017; Lot Number: 14012987X, Expiration Date: 2/17/2017; Lot Number: 14014736X, Expiration Date: 3/11/2017; Lot Number: 14016577X, Expiration Date: 3/26/2017; Lot Number: 14017912X, Expiration Date: 4/27/2017; Lot Number: 14020280X, Expiration Date: 5/21/2017; Lot Number: 14022920X, Expiration Date: 6/19/2017; Lot Number: 14024168X, Expiration Date: 6/22/2017; Lot Number: 14026031X, Expiration Date: 7/27/2017; Lot Number: 14028553X, Expiration Date: 8/12/2017; Lot Number: 14029477X, Expiration Date: 8/26/2017; Lot Number: 14033830X, Expiration Date: 10/14/2017; Lot Number: 14036315X, Expiration Date: 11/17/2017; Accurus 25+ 2500 CPM Stand-Alone Vitreous Probe: Lot Number: 14010429X, Expiration Date: 1/14/2014; Lot Number: 14012985X, Expiration Date: 2/17/2017; Lot Number: 14014737X Expiration Date: 3/11/2017; Lot Number: 14016477X Expiration Date: 3/26/2017; Lot Number: 14018320X Expiration Date: 4/27/2017; Lot Number: 14020282X Expiration Date: 5/21/2017; Lot Number: 14022922X Expiration Date: 6/19/2017; Lot Number: 14026032X Expiration Date: 7/27/2017; Lot Number: 14028554X Expiration Date: 8/12/2017; Lot Number: 14033831X Expiration Date: 10/15/2017; Lot Number: 14036315X Expiration Date: 11/16/2017; Anterior Accurus Probe with Infusion Needle: Lot Number: 14010430X Expiration Date: 1/14/2017; Lot Number: 14012984X Expiration Date: 2/17/2017; Lot Number: 14014739X Expiration Date: 3/11/2017; Lot Number: 14017451X Expiration Date: 4/15/2017; Lot Number: 14020283X Expiration Date: 5/21/2017; Lot Number: 14022923X Expiration Date: 6/19/2017; Lot Number: 14024219X Expiration Date: 6/22/2017; Lot Number: 14026034X Expiration Date: 7/27/2017; Lot Number: 14028555X Expiration Date: 8/12/2017; Lot Number: 14031264X Expiration Date: 9/22/2017; Lot Number: 14033832X Expiration Date: 10/15/2017; Accurus 2500 Stand-Alone Vitreous Probe: Lot Number: 14014738X Expiration Date: 3/11/2017; Lot Number: 14017452X Expiration Date: 4/15/2017; Lot Number: 14020246X Expiration Date: 5/21/2017; Lot Number: 14022921X Expiration Date: 6/19/2017; Lot Number: 14026030X Expiration Date: 7/27/2017; Lot Number: 14028440X Expiration Date: 8/6/2017; Lot Number: 14031263X Expiration Date: 9/22/2017; Lot Number: 14033833X Expiration Date: 10/15/2017; Lot Number: 14036297X Expiration Date: 11/16/2017 |
Recalling Firm/
Manufacturer |
Alcon Research, Ltd.
6201 South Fwy
Fort Worth TX 76134-2099
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| For Additional Information Contact |
817-293-0450
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Manufacturer Reason
for Recall |
Insufficient seal on the outside packaging, potentially affecting the sterility of the product.
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FDA Determined
Cause 2 |
Packaging |
| Action |
Recall notification letters were sent to consignees on June 2, 2015. |
| Quantity in Commerce |
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, Poland, Russia, Spain, Sri Lanka, Switzerland, Taiwan, Thailand, Turkey, and United Kingdom. |
| Total Product Life Cycle |
TPLC Device Report
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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| 510(K) Database |
510(K)s with Product Code = HQC and Original Applicant = ALCON LABORATORIES
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