INFINITI VISION SYSTEM ULTRASOUND FMS. Single-use fluid management system. STERILE. Model Number...
FDA Device Recall #Z-0506-2015 — Class II — October 30, 2014
Recall Summary
| Recall Number | Z-0506-2015 |
| Classification | Class II — Moderate risk |
| Date Initiated | October 30, 2014 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Alcon Research, Ltd. |
| Location | Fort Worth, TX |
| Product Type | Devices |
| Quantity | 147,473 units |
Product Description
INFINITI VISION SYSTEM ULTRASOUND FMS. Single-use fluid management system. STERILE. Model Numbers: 8065741080, 8065741081, 8065741082, 8065741083, 8065741085, 8065741087, 8065741088, 8065741089, 8065741093, 8065741096, 8065741097, 8065741099, 8065750266, 8065750268, 8065750274, 8065750278, 8065750280, 8065750281, 8065751009, 8065751010, 8065751011, 8065751716, 8065751717, 8065751718, 8065751719, 8065751720, 8065751721, 8065751722, 8065751723, 8065751724 The INFINITI Vision system is indicated for emulsification, separation, and removal of cataracts, the removal of residual cortical material and lens epithelial cells, vitreous aspiration and cutting associated with anterior vitrectomy, bipolar coagulation, and intra-ocular lens injection.
Reason for Recall
Alcon is conducting a medical device recall due to the possible presence of pieces of tubing in the aspiration line.
Distribution Pattern
Worldwide Distribution: US (nationwide) and countries of: Canada, Mexico, Australia, Belgium, Hong Kong, Japan, Bosnia, France, Estonia, Germany, Greece, Hungary, Iceland, Israel, Iraq, Latvia, Saudi Arabia, Spain, UAE, Paraguay, Pakistan, Vietnam, and Kurdistan.
Lot / Code Information
Lot Numbers: 1623755H, 1623756H, 1637071H, 1637072H, 1637073H, 1642718H, 1642719H, 1642720H, 1642721H, 1644878H, 1647623H, 1647624H, 1647625H, 1647626H, 1647627H, 1647628H, 1647973H, 1647974H, 1647975H, 1647976H, 1647977H, 1652900H, 1652901H, 1652904H, 1652905H, 1652906H, 1653115H, 1653116H, 1653117H, 1653119H, 1653357H, 1653358H, 1653359H, 1628801H, 1634593H, 1634594H, 1634595H, 1634596H, 1634597H, 1634598H, 1636464H, 1636465H, 1636466H, 1636467H, 1636468H, 1636469H, 1637069H, 1637070H, 1642428H, 1642429H, 1642430H, 1642431H, 1642432H, 1642433H, 1642478H, 1642479H, 1642480H, 1642481H, 1642482H, 1642919H, 1642920H, 1645688H, 1645689H, 1645690H, 1647792H, 1647793H, 1647794H, 1652897H, 1652898H, 1652899H, 1652902H, 1652903H, 1647572H, 1647573H, 1647789H, 1647790H, 1647791H, 1623130H, 1639845H, 1639846H, 1639847H, 1639848H, 1642518H, 1647969H, 1647970H, 1647971H, 1647972H, 1631281H, 1631566H, 1631567H, 1631568H, 1645638H, 1645752H, 1647576H, 1650024H, 1642677H, 1647896H, 1634767H, 1637202H, 1640123H, 1642678H, 1642724H, 1642725H, 1645640H, 1634748H, 1634749H, 1637201H, 1647571H, 1642728H, 1645753H, 1650025H, 1634768H, 1642680H, 1647569H, 1647570H, 1650440H, 1634750H, 1645754H, 1652969H, 1642682H, 1650844H, 1650845H, 1642683H, 1623132H, 1623761H, 1645641H, 1650608H, 1623134H, 1628712H, 1628713H, 1628714H, 1631846H, 1637064H, 1637065H, 1637203H, 1637204H, 1642684H, 1642688H, 1642723H, 1643014H, 1645642H, 1645643H, 1650026H, 1650027H, 1650430H, 1650609H, 1650610H, 1653317H, 1653318H, 1610411H, 1636450H, 1636451H, 1642534H, 1642535H, 1628716H, 1640124H, 1640125H, 1640126H, 1640127H, 1650847H, 1653070H, 1634763H, 1634764H, 1647786H, 1647785H, 1650848H, 1653069H, 1628072H, 1628073H, 1636431H, 1637205H, 1645646H, 1650611H, 1631847H, 1637066H, 1637067H, 1652950H, 1652958H, 1652959H, 1634765H, 1636429H, 1636430H, 1639661H, 1639662H, 1642537H, 1645647H, 1647967H, 1647968H, 1650028H, 1650029H, 1650612H, 1631559H, 1639851H, 1639852H, 1636405H, 1636406H, 1645686H, 1645687H, 1634769H, 1637206H, 1639849H, 1639850H, 1645648H, 1647854H, 1650030H, 1631529H, 1631534H, 1631535H, 1639483H, 1645207H, 1645684H, 1645685H, 1653347H, 1653348H, 1653349H, 1653350H, 1628719H, 1631848H, 1636407H, 1637207H, 1645649H, 1650031H, 1650614H, 1631849H, 1634766H, 1642516H, 1642687H, 1645650H, 1650615H.
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.