Paragon BioTeck has obtained 510(k) clearance from the US Food and Drug Administration (FDA) for its Comfortear Lacrisolve Absorbable Punctum Plug, a medium-term implant designed to be inserted into the canaliculus to block tear drainage through the lacrimal drainage system.
Paragon BioTeck Quality Assurance director Lauren M-C Bluett said that receiving FDA 510(k) clearance for this device is an important milestone for the company.
"Dry eye affects over 4.8 million people in the U.S. and, keeping with Paragon’s ultimate goal to protect and preserve eyesight, the Comfortear Lacrisolve Absorbable Punctum Plug is a great addition to our portfolio of FDA regulated ophthalmic products," Bluett added..
The Comfortear Lacrisolve Absorbable Punctum Plug includes the synthetic absorbable polymer, polydioxanone. Absorption time for the plugs is approximately six months.
The Comfortear Lacrisolve Absorbable Punctum Plugs are available in 0.4mm and 0.5mm diameters. The plugs will ship beginning July 2014.