TECNIS Multifocal 1-Piece Intraocular Lens, Model No. ZKB00, ZLB00; The product is indicated fo...
FDA Device Recall #Z-2856-2016 — Class II — August 26, 2016
Recall Summary
| Recall Number | Z-2856-2016 |
| 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 | 77 units |
Product Description
TECNIS Multifocal 1-Piece Intraocular Lens, Model No. ZKB00, ZLB00; The product is indicated for 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 who desire near, intermediate, and distance vision with 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
ZKB00 Serial No. 8667461602 8667751602 8667471602 8667761602 8667481602 8667771602 8667491602 8667781602 8667501602 8667801602 8667511602 8667811602 8667521602 8667821602 8667531602 8667831602 8667541602 8667841602 8667551602 8667851602 8667561602 8667861602 8667571602 8667871602 8667581602 8667881602 8667591602 8667891602 8667601602 8667901602 8667611602 8667911602 8667621602 8667921602 8667631602 8667931602 8667641602 8667961602 8667661602 8667971602 8667671602 8667981602 8667681602 8667991602 8667691602 8668001602 8667701602 8668011602 ZLB00 Serial No. 8960421506 8960431506 8960441506 8960451506 8960461506 8960471506 8960481506 8960501506 8960511506 8960531506 8960541506 8960581506 8960591506 8960621506 8960631506 8960641506 8960651506 8960661506 8960671506 8960681506 8960691506 8960701506 8960711506 8960721506 8960731506 8960741506
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-2062-2017 | Class II | Healon, Part No. 10290953, 10295210, 10200011, ... | Apr 1, 2017 |
| Z-2063-2017 | Class II | Healon GV, Part No. 10294701, 10294801, 1020001... | Apr 1, 2017 |
| Z-2065-2017 | Class II | Healon 5 Pro, Part No. 10270015 | Apr 1, 2017 |
| Z-2066-2017 | Class II | Healon Pro, Part No. 10270012 | 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.