device · product 1 of 1
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.
- Recall number
- Z-0506-2015
- Initiated
- October 30, 2014
- Classification
- Class II
- Status
- Terminated
- Recalling firm
- Alcon Research, Ltd.
- Quantity
- 147,473 units
App-derived interpretation
Alcon is conducting a medical device recall due to the possible presence of pieces of tubing in the aspiration line.
Official device-enrichment evidence · Sourced
Process control
Inspect official wording and provenance
Reason for recall
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.