TECNIS OptiBlue 1-Piece Intraocular Lens (IOL), Model No. ZCB00V The product is indicated for im...
FDA Device Recall #Z-2859-2016 — Class II — August 26, 2016
Recall Summary
| Recall Number | Z-2859-2016 |
| 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 | 131 units |
Product Description
TECNIS OptiBlue 1-Piece Intraocular Lens (IOL), Model No. ZCB00V The product is indicated for implantation for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction. 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. 2624401411 2624411411 2624421411 2624431411 2624441411 2624451411 2624461411 2624471411 2624481411 2624491411 2624501411 2624511411 2624521411 2624531411 2624541411 2624551411 2624561411 2624571411 2624581411 2624591411 2624601411 2624611411 2624621411 2624631411 2624641411 2624651411 2624661411 2624671411 2624681411 2624691411 2624701411 2624711411 5259101407 5259111407 5259121407 5259131407 5259141407 5259151407 5259161407 5259171407 5259181407 5259191407 5259201407 5259211407 5259221407 5259231407 5259241407 5259251407 5259261407 5259271407 5259281407 5259291407 5259301407 5259311407 5259321407 5259331407 5259341407 5259351407 5259361407 5259371407 5259381407 5259391407 5259401407 5259411407 5259421407 5259431407 5259441407 5259451407 5259461407 5259471407 5259481407 5259491407 5259501407 5259511407 5259521407 5259531407 5259541407 5259551407 5259561407 5259571407 5259581407 5259591407 5259601407 5259611407 5259621407 5259631407 5259641407 5259651407 5259661407 5259671407 5259681407 5259691407 5259701407 5259711407 5259721407 5259731407 5259741407 5259751407 5259761407 5259771407 5259781407 5259791407 5259801407 5259811407 5259821407 5259831407 5259841407 5259851407 5259861407 5259871407 5259881407 5259891407 5259901407 5259911407 5259921407 5259931407 5259941407 5259951407 5259961407 5259971407 5259981407 5259991407 5260001407 5260011407 5260021407 5260031407 5260041407 5260051407 5260061407 5260071407 5260081407
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.