|Trade Name||STAARVISC TM SODIUM HYALURONATE|
|Generic Name||sodium hyaluronate|
|Docket Number|| 99M-4693|
|Expedited Review Granted?|| No|
||Labeling, Approval Order, Summary of Safety and Effectiveness|
|Approval Order Statement |
Approval for the staarvisc(tm) sodium hyaluronate viscoelastic. This device is indicated for use as a surgical aid in ophthalmic anterior and posterior segment surgery including: 1) cataract extraction with or without implantation of an intraocular lens; 2) corneal transplant surgery; 3) glaucoma filtering surgery; and secondary lens implantation. Staarvisc(tm) aids in maintaining a deep anterior chamber during surgery, protecting corneal endothelial and surrounding tissues from touch by instruments or intraocular lenses, inflating the capsular bag after cataract extraction and lubricating surgical instruments.