Device product
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.
Z-0506-2015
Product summary
- Event
- Event 69673
- Status
- Terminated
- Classification
- Class II
- Quantity
- 147,473 units
- Official record key
device-enforcement:Z-0506-2015
Official wording
Reason: Alcon is conducting a medical device recall due to the possible presence of pieces of tubing in the aspiration line.
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.
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.
Derived failure modes
-
Unknown
Alcon is conducting a medical device recall due to the possible presence of pieces of tubing in the aspiration line.