TECNIS Symfony Extended Range of Vision IOL, Model No. ZXR00 The product is indicated primary im...
FDA Device Recall #Z-2857-2016 — Class II — August 26, 2016
Recall Summary
| Recall Number | Z-2857-2016 |
| Classification | Class II — Moderate risk |
| Date Initiated | August 26, 2016 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Abbott Medical Optics Inc. (AMO) |
| Location | Santa Ana, CA |
| Product Type | Devices |
| Quantity | 10 units |
Product Description
TECNIS Symfony Extended Range of Vision IOL, Model No. ZXR00 The product is indicated primary implantation for the visual correction of aphakia in adult patients with and without presbyopia in whom a cataractous lens has been removed by extracapsular cataract extraction, and aphakia following refractive lensectomy in presbyopic adults, who desire useful vision over a continuous range of distances including far, intermediate and near, and increased spectacle independence. The lens is intended to be placed in the capsular bag.
Reason for Recall
Abbott Medical Optics is recalling Intraocular Lenses (IOLs) because they were not being checked prior to release and this may result in the release of mislabeled IOLs.
Distribution Pattern
Worldwide Distribution - US nationwide, PR, and Internationally to Canada, Latin America, Europe, Africa, Middle East, and Asia Pacific.
Lot / Code Information
Serial No. 8618391605 8618441605 8231911605 8231921605 8231931605 8231961605 8496921508 8496931508 8496941508 8496951508
Other Recalls from Abbott Medical Optics Inc. (AMO)
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-2064-2017 | Class II | Healon Duet, Part No. 10290080, 10220010, 10220... | Apr 1, 2017 |
| Z-2063-2017 | Class II | Healon GV, Part No. 10294701, 10294801, 1020001... | Apr 1, 2017 |
| Z-2062-2017 | Class II | Healon, Part No. 10290953, 10295210, 10200011, ... | Apr 1, 2017 |
| Z-2066-2017 | Class II | Healon Pro, Part No. 10270012 | Apr 1, 2017 |
| Z-2065-2017 | Class II | Healon 5 Pro, Part No. 10270015 | Apr 1, 2017 |
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.