Recall Z-0506-2015 ยท HQC Unit, Phacofragmentation
Alcon Research, Ltd.
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, 806575171
| Date | Dec 4, 2014 (initiated Oct 30, 2014) |
| Status | Terminated |
| Reason | Alcon is conducting a medical device recall due to the possible presence of pieces of tubing in the aspiration line. |
| Root cause | Process control |
| Action | The firm, Alcon, sent an "URGENT: MEDICAL DEVICE VOLUNTARY RECALL" letter dated October 30, 2014 to all customers. The letter described the product, problem and actions to be taken. The customers were instructed to immediately stop further use of the affected INFINITI FMS; review your inventory to determine if you have any affected units; segregate the potentially-affected product to ensure it is not used; complete and return the attached Response Form via fax: 817-302-4337 or email: Market.Actions@Alcon.com to Alcon, even if you have zero(0) units in inventory; immediately forward to all depa |
| Quantity | 147,473 units |
| Distribution | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K120912 | INFINITI(R) VISION SYSTEM Alcon Manufacturing, Ltd., Jun 15, 2012 |