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The Comfortear® Lacrisolve™ Absorbable Punctum Plugs are intended to temporarily block tear drainage by the occlusion of the canaliculus in order to: - Determine the potential effectiveness of permanent occlusion, . - Temporarily treat dry eye syndrome, and the dry eye components of various ocular . surface diseases, - . Temporarily enhance the efficacy of topical medications or ocular lubricants. - . Temporarily treat contact lens intolerance secondary to dry eye, and - Temporarily treat dry eye after ocular surgery.

Comfortear® Lacrisolve™ Absorbable Punctum Plugs are intended to temporarily block tear drainage by occlusion of the canaliculus. The plug is supplied in various sizes ranging from 0.2mm to 0.5mm in diameter and has a length of approximately 1.75mm, see table below. The plug is dyed (D&C Violet No. 2). Comfortear® Lacrisolve™ Absorbable Punctum Plugs are composed of the following absorbable suture materials: polydioxanone (PDO). The design features of the Comfortear@ Lacrisolve™ Absorbable Punctum Plugs raise no new issues of safety or effectiveness. Comfortear® Lacrisolve™ Absorbable Punctum Plugs consist of a length of monofilament synthetic absorbable suture material. The Comfortear® Lacrisolve™ Absorbable Punctum Plugs are provided sterile. The Comfortear® Lacrisolve™ Absorbable Punctum Plugs are available in various sizes to accommodate different patient physiologies and achieve occlusion of the canaliculus (or punctum). Two plugs are included in each package and there is one package in each box. This device is sub-punctal, to limit contact and possible irritation to the eye.