Reported Dec 10, 2014 · Terminated

INFINITI VISION SYSTEM ULTRASOUND FMS. Single-use fluid management system. STERILE. Model Numbers: 8065741080,…

Alcon Research, Ltd.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Alcon Research, Ltd. · 6201 South Fwy · Fort Worth, TX · 76134-2099

Is this the product you have?

  • INFINITI VISION SYSTEM ULTRASOUND FMS. Single-use fluid management system. STERILE
  • Model Numbers8065741080, 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
Lot codes and dates
  • Lot Numbers

    229 of 229 codes

    • 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
Amount recalled
147,473 units

Where it was sold

  • Nationwide

Why it was recalled

Alcon is conducting a medical device recall due to the possible presence of pieces of tubing in the aspiration line.

This product could cause temporary or reversible health problems — stop using it.

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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Oct 9, 2015 · Data as of Sep 19, 6:07 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.