Food, drugs, devices › Alcon Research, Ltd.
Device recall: Accurus 2500 Standalone Vitreous Probe REF 8065741018; Accurus 23 GA Standalone Vitreous Probe REF 8065750821; Accurus 2
FDA enforcement event 71383 is a device recall by Alcon Research, Ltd. of Fort Worth, TX, initiated 2 Jun 2015 and classified Class II, with 1 product record.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 91% of the 1,153 device enforcement events initiated in 2015 carry the same class.
Status: Terminated, terminated 20 Apr 2017. Initiation: voluntary: firm initiated. Alcon Research, Ltd. has 28 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Alcon Research, Ltd., Fort Worth, TX.
Reason for recall
"Insufficient seal on the outside packaging, potentially affecting the sterility of the product."
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,…"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1940-2015 | 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… | 35,475 units | Class II | Terminated | 8 Jul 2015 |
Context
Other enforcement events for Alcon Research, Ltd.
All 28 events for Alcon Research, Ltd.
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "Insufficient seal on the outside packaging, potentially affecting the sterility of the product."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "Worldwide Distribution-US (nationwide) and the countries of Argentina, Australia, Austria, Brazil, Canada, Chile, China, Colombia, Czech Republic, France, Germany, Hong Kong, Hungary, India,…"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 20 Apr 2017. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.