|Trade Name||CEEON HEPARIN SURFACE MODIFIED (ASM) ULTRAVIOLET LIGHT.|
|Generic Name||posterior chamber intraocular lenses|
|Applicant||ABBOTT MEDICAL OPTICS INC|
|Docket Number|| 98M-0725|
|Notice Date|| 10/27/1998|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for lens models with the heparin surface modification applied to all your single-piece pmma lenses approved in p810055. These models will be specified with a "c" following the number designation for the corresponding non-hsm pmma model. The lenses will be marketed under the trade name ceeon(tm) hsm pmma iols. This device is indicated for primary implantation for the visual correction of aphakia in adults in whom a cataractous lens has been removed by an extracapsular cataract extraction (ecce) or phacoemulsification. They are intended to be placed in the capsular bag.