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 Accurus vitrectomy console.

Recall number

Z-1940-2015

Recalling firm

Alcon Research, Ltd.

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.

Status

Terminated

Initiated

2015-06-02

Posted

2015-06-29

Terminated

2017-04-20

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, Poland, Russia, Spain, Sri Lanka, Switzerland, Taiwan, Thailand, Turkey, and United Kingdom.

Lot, serial or model codes

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

510(k) numbers

["K911808"]

PMA numbers

not on file

Product code

HQC

Firm FEI

1610287

Firm city

Fort Worth

Firm state

TX

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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