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Alcon Research, Ltd. recalls Custom Paks containing 23G and 25G valved trocar cannula provide access into the posterior segment of the eye for surgic
Recalled May 25, 2016 · FDA recall Z-1694-2016 · Alcon Research
Hazard
The product has potential to leak beyond their design specification. · FDA Class II
Units
30,701 units
Sold at
United States, Argentina, Armenia, Australia, Azerbaijan, Bangladesh, Brbados, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Curacao, Cypress, Denmark, Ecuador, Finland, Germany, Greece, Hong Kong, Hungary, Iceland, India, Ireland, Lsreal, Italy, Japan, Korea, Lithuania, Malta, Mexico, Monaco, Netherlands, New Zealand, Pakistam, Philippines, Poland, Prtougal, Puerto Rico, Romania, Russia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Trinidad, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay
Description
The product has potential to leak beyond their design specification.
Product
Custom Paks containing 23G and 25G valved trocar cannula provide access into the posterior segment of the eye for surgical instruments within the frame of 23G and 25G Pars-Plana-Vitrectomy (PPV) surgeries.
Manufacturer(s)
Alcon Research, Ltd.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →