Recall Z-0506-2015
Alcon Research, Ltd. · initiated October 30, 2014
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: Lot Numbers: 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, 1642920H, 1645688H, 1645689H, 1645690H, 1647792H, 1647793H, 1647794H, 1652897H, 1652898H, 1652899H, 1652902H, 1652903H, 1647572H, 1647573H, 1647789H, 1647790H, 1647791H, 1623130H, 1639845H, 1639846H, 1639847H, 1639848H, 1642518H, 1647969H, 1647970H, 1647971H, 1647972H, 1631281H, 1631566H, 1631567H, 1631568H, 1645638H, 1645752H, 1647576H, 1650024H, 1642677H, 1647896H, 1634767H, 1637202H, 1640123H, 1642678H, 1642724H, 1642725H, 1645640H, 1634748H, 1634749H, 1637201H, 1647571H, 1642728H, 1645753H, 1650025H, 1634768H, 1642680H, 1647569H, 1647570H, 1650440H, 1634750H, 1645754H…
Reason for recall
Alcon is conducting a medical device recall due to the possible presence of pieces of tubing in the aspiration line.
FDA-determined cause: Process control
Action taken
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 departments within your organization who may be using or order the Alcon INFINITI Fluidic Management System (FMS), and ensure that a copy of this notification is provided to any other organizations to which the affected device lots have been transferred. Please Note: Replacement stock will be issued for units that are returned to Alcon. An Alcon Customer Service Representative will work with you to place a new order to replace the affected units. Contact Alcon Customer Service at +1-900-862-5266 to arrange for the return or your inventory. If you have any further questions or need assistance with obtaining replacement products, please contact Alcon Customer Service at +1-900-862-5266 and we will assist you.
Details
- Recall number
- Z-0506-2015
- Initiated
- October 30, 2014
- Posted by FDA
- December 4, 2014
- Terminated
- October 9, 2015
- Product code
- HQC – Unit, Phacofragmentation
- 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.
- Recalling firm
- Alcon Research, Ltd., Fort Worth, TX