|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 ACCOMMODATING POSTERIOR CHAMBER INTRAOCULAR LENS (AIOL), MODELS AT-45-HD100, HD500, AND HD520|
|Applicant||BAUSCH & LOMB, INC.|
|Supplement Type||normal 180 day track|
|Supplement Reason|| change design/components/specifications - component|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval to market the following models in 0. 5 diopter increments: models at-45-hd100 (10 to 33 diopters), hd500 (17. 0 to 33. 0 diopters), and hd520 (10 to 16. 5 diopters). Additionally, approval to recommend use of the staar msi-pr/tr and msi-pf/tf injectors with mtc-60c cartridge to deliver these lens models.