INFINITI VISION SYSTEM ULTRASOUND FMS — Class II medical device recall Z-0506-2015
Terminated recall by Alcon Research, Ltd., reported 2014-12-10, distributed nationwide. Alcon is conducting a medical device recall due to the possible presence of pieces of tubing in the aspiration
| Recall number | Z-0506-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Alcon Research, Ltd., Fort Worth, TX, United States |
| Recall initiated | 2014-10-30 |
| Classified | 2014-12-04 |
| Reported by FDA | 2014-12-10 |
| Terminated | 2015-10-09 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AU, BE, CA, DE, EE, ES, FR, GR, HK, HU, IL, IQ, IS, JP, LV, MX, PK, PY, SA, VN |
| Quantity | 147,473 units |
| Lot numbers | 1610411H, 1623130H, 1623132H, 1623134H, 1623755H, 1623756H, 1623761H, 1628072H, 1628073H, 1628712H, 1628713H, 1628714H, 1628716H, 1628719H, 1628801H, 1631281H, 1631529H, 1631534H, 1631535H, 1631559H, 1631566H, 1631567H, 1631568H, 1631846H, 1631847H, 1631848H, 1631849H, 1634593H, 1634594H, 1634595H, 1634596H, 1634597H, 1634598H, 1634748H, 1634749H, 1634750H, 1634763H, 1634764H, 1634765H, 1634766H and 189 more |
| 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 and 5 more |
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.
Reason for recall
Alcon is conducting a medical device recall due to the possible presence of pieces of tubing in the aspiration line.
Machine access
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Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.