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Alcon Research, Ltd. recalls 23G and 25G Constellation Totalplus Paks provides access into the posterior segment of the eye for surgical instruments
Recalled May 25, 2016 · FDA recall Z-1693-2016 · Alcon Research
Hazard
The product has potential to leak beyond their design specification. · FDA Class II
Units
225,000 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
23G and 25G Constellation Totalplus Paks provides 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 →