|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 INTRACULAR LENS (IOL)|
|Applicant||BAUSCH & LOMB, INC.|
|Supplement Type||real-time process|
|Supplement Reason|| labeling change - instructions|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval to modify the physician¿s labeling to include the addition of 0. 25 diopter increments for the crystalens model hd500 and hd520 as follows: the addition of 0. 25 diopter increments for model hd500 lenses in the +18 to +22 dioptric power range and for model hd520 lenses in the +16. 25 to +16. 75 dioptric power range.