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.
Reported: May 25, 2016 Initiated: August 11, 2015 #Z-1693-2016
Product Description
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.
Reason for Recall
The product has potential to leak beyond their design specification.
Details
- Recalling Firm
- Alcon Research, Ltd.
- Units Affected
- 225,000 units
- Distribution
- 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
- Location
- Fort Worth, TX
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Alcon Research, Ltd.. Units affected: 225,000 units.
Why was this product recalled? ▼
The product has potential to leak beyond their design specification.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 25, 2016. Severity: Moderate. Recall number: Z-1693-2016.
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