|Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.|
|Trade Name||CRYSTALENS MODEL AT-45 ACCOMMODATING INTRAOCULAR LENS|
|Applicant||BAUSCH & LOMB, INC.|
|Supplement Type||normal 180 day track|
|Supplement Reason|| change design/components/specifications - material|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval to market crystalens® model at-45 accommodating intraocular lens (iol) with a benzotriazole ultra-violet (uv) absorber chromophore (uvam). To be designated as models at1uv, at2uv, hd1uv, hd2uv, ao1uv and ao2uv.