The Recall Desk
ModerateFDA (Devices)·Z-1940-2015·Announced 2015-07-08

Alcon Accurus Vitreous Probes Recalled for Packaging Seal Defect

Alcon Research is recalling Accurus vitreous probes due to insufficient outer packaging seals that may compromise sterility.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II. The hazard is a potential loss of sterility due to packaging defects, which is a significant risk but does not meet the criteria for Severe (Class II with hospitalization reports) or Critical (Class I). It is higher than Low because it involves a sterile medical device where sterility is critical to patient safety.

Plain-English summary

Alcon Research, Ltd. is recalling specific lots of Accurus standalone vitreous probes and anterior probes with infusion needles. The recall is due to an insufficient seal on the outside packaging, which potentially affects the sterility of the single-use sterile products. These devices are intended for use by surgeons performing vitrectomy procedures with the Alcon Accurus vitrectomy console.

The affected products include the Accurus 2500 Standalone Vitreous Probe, Accurus 23 GA Standalone Vitreous Probe, Accurus 25+ 2500 CPM Standalone Vitreous Probe, and Anterior Accurus Probe with Infusion Needle. A total of 35,475 units are involved in this recall. The products were distributed nationwide in the United States and in numerous countries worldwide, including Argentina, Australia, Austria, Brazil, Canada, Chile, China, Colombia, Czech Republic, France, Germany, Hong Kong, Hungary, India, Italy, Japan, Kenya, Korea, Kosovo, Malaysia, Mexico, Morocco, Netherlands, New Zealand, Poland, Russia, Spain, Sri Lanka, Switzerland, Taiwan, Thailand, Turkey, and the United Kingdom.

Healthcare providers and facilities should stop using the affected lots and contact Alcon Research for instructions on return or replacement. Patients who have had surgery using these devices should contact their healthcare provider if they have concerns about the procedure or experience any complications.

The recalled product

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
Manufacturer
Alcon Research, Ltd.
Category
Medical Device — Surgical Instruments
Hazard
Affected units
35,475

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • 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

Distribution

Distributed nationwide across the United States.

Related recalls

Same manufacturer · Alcon Research, Ltd.

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Same hazard · sterility compromise

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