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.
FDA Recall Z-1693-2016 · Posted 2016-05-18
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Recalling FirmAlcon Research, Ltd.
Recall StatusTerminated
Product CodeNGY
Date Initiated2015-08-11
Date Terminated2017-04-20
Product Quantity225,000 units
Reason for Recall
The product has potential to leak beyond their design specification.
Firm Action
The affected consignees were contacted via letter on 8/11/15 to communicate the potential for leakage.
Root Cause
Process control
Distribution Pattern
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
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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