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U.S. Department of Health and Human Services

Class 2 Device Recall INFINITI(R) VISION SYSTEM

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 Class 2 Device Recall INFINITI(R) VISION SYSTEMsee related information
Date Initiated by FirmOctober 30, 2014
Date PostedDecember 04, 2014
Recall Status1 Terminated 3 on October 09, 2015
Recall NumberZ-0506-2015
Recall Event ID 69673
510(K)NumberK120912 
Product Classification Unit, phacofragmentation - Product Code HQC
ProductINFINITI 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.
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.
Recalling Firm/
Manufacturer
Alcon Research, Ltd.
6201 South Fwy
Fort Worth TX 76134-2099
For Additional Information Contact
817-293-0450
Manufacturer Reason
for Recall
Alcon is conducting a medical device recall due to the possible presence of pieces of tubing in the aspiration line.
FDA Determined
Cause 2
Process control
ActionThe firm, Alcon, sent an "URGENT: MEDICAL DEVICE VOLUNTARY RECALL" letter dated October 30, 2014 to all customers. The letter described the product, problem and actions to be taken. The customers were instructed to immediately stop further use of the affected INFINITI FMS; review your inventory to determine if you have any affected units; segregate the potentially-affected product to ensure it is not used; complete and return the attached Response Form via fax: 817-302-4337 or email: Market.Actions@Alcon.com to Alcon, even if you have zero(0) units in inventory; immediately forward to all departments within your organization who may be using or order the Alcon INFINITI Fluidic Management System (FMS), and ensure that a copy of this notification is provided to any other organizations to which the affected device lots have been transferred. Please Note: Replacement stock will be issued for units that are returned to Alcon. An Alcon Customer Service Representative will work with you to place a new order to replace the affected units. Contact Alcon Customer Service at +1-900-862-5266 to arrange for the return or your inventory. If you have any further questions or need assistance with obtaining replacement products, please contact Alcon Customer Service at +1-900-862-5266 and we will assist you.
Quantity in Commerce147,473 units
DistributionWorldwide 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.
Total Product Life CycleTPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = HQC
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