This voluntary medical device correction is related to Alcon products that present a 23G nonvalve...
FDA Device Recall #Z-2470-2012 — Class II — May 29, 2012
Recall Summary
| Recall Number | Z-2470-2012 |
| Classification | Class II — Moderate risk |
| Date Initiated | May 29, 2012 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Alcon Research, LTD. |
| Location | Houston, TX |
| Product Type | Devices |
| Quantity | 93,319 (30, 413 distributed domestically & 62,906 internationally) |
Product Description
This voluntary medical device correction is related to Alcon products that present a 23G nonvalved trocar cannula and infusion cannula together. These items are available as components within Accurus 23G TotalPLUS Pak, Accurus 23G Combined Procedure Packs (0.9mm and 1.1mm), Constellation 23G Total PLUS Pak, Constellation 23G Combined Pack (0.9 mm and 1.1 mm) and 23G Small Parts Kit. Single use 23G non-valved trocar cannulas are used to provide internal access to the ocular cavity during ophthalmic surgery. Single use infusion cannulas are used for the infusion of fluid or air during ophthalmic surgery to maintain intraocular pressure during posterior segment surgeries.
Reason for Recall
This medical device correction is related to Alcon products that present a 23G non-valved trocar cannula and infusion cannula together because of an issue regarding the loose fit between the 23G non-valved trocar cannula and infusion cannula that could potentially cause a detachment between the non-valved trocar cannula and infusion cannula during surgery.
Distribution Pattern
Worldwide Distribution - USA (nationwide) and the countries of Saudi Arabia, United Kingdom, Greece, Singapore, Germany, Switzerland, Kuwait, United Arabian Emirates, and Austria.
Lot / Code Information
1) 23G TotalPLUS Pak: Accurus Standalone - 8065750828, 2) 23G Combined Pack 0.9mm: Accurus Standalone - 8065750814, 3) 23G Combined Pack 1.1mm: Accurus Standalone - 8065750816, 4)23G TotalPLUS Pak: Constellation Standalone - 8065751058, 5) 23G Combined Pack 0.9mm: Constellation Standalone -8065751077, 6) 23G Combined Pack 1.1mm: Constellation Standalone - 8065751065. 7) 23G Small Parts Kit - 8065750842. Complete list of lot numbers will be provided with recall recommendation.
Other Recalls from Alcon Research, LTD.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-2408-2023 | Class II | Infinity FMS Pak | Jun 28, 2023 |
| Z-2407-2023 | Class II | Centurion FMS Pak | Jun 28, 2023 |
| Z-2406-2023 | Class II | Constellation Procedure Pak | Jun 28, 2023 |
| Z-2410-2023 | Class II | Phaco Standalone Tips | Jun 28, 2023 |
| Z-2411-2023 | Class II | Alcon Custom Pak | Jun 28, 2023 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.