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
1623755H1623756H1637071H1637072H1637073H1642718H1642719H1642720H1642721H1644878H1647623H1647624H1647625H1647626H1647627H1647628H1647973H1647974H1647975H1647976H1647977H1652900H1652901H1652904H1652905H1652906H1653115H1653116H1653117H1653119H1653357H1653358H1653359H1628801H1634593H1634594H1634595H1634596H1634597H1634598H1636464H1636465H1636466H1636467H1636468H1636469H1637069H1637070H1642428H1642429H1642430H1642431H1642432H1642433H1642478H1642479H1642480H1642481H1642482H1642919H
- Lot Numbers
- 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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