Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
INFINITI VISION SYSTEM ULTRASOUND FMS. Single-use fluid management system. STERILE. Recalled by Alcon Research, Ltd. Due to Alcon is conducting a medical device recall due...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Alcon Research, Ltd. directly.
Affected Products
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.
Quantity: 147,473 units
Why Was This Recalled?
Alcon is conducting a medical device recall due to the possible presence of pieces of tubing in the aspiration line.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Alcon Research, Ltd.
Alcon Research, Ltd. has 26 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report