| Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling. |
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| Device | AKREOS POSTERIOR CHAMBER INTRAOCULAR LENS,MODEL ADAPT |
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| Generic Name | intraocular lens |
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| Regulation Number | 886.3600 |
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| Applicant | Bausch & Lomb, Inc.
50 Technology Drive
Irvine, CA 92618 |
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| PMA Number | P060022 |
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| Date Received | 06/29/2006 |
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| Decision Date | 09/05/2008 |
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| Product Code |
HQL |
| Docket Number | 08M-0515 |
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| Notice Date | 09/19/2008 |
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| Advisory Committee |
Ophthalmic |
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| Expedited Review Granted? | No |
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| Combination Product | No |
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| Recalls | CDRH Recalls |
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Approval Order Statement
APPROVAL FOR THE AKREOS POSTERIOR CHAMBER INTRAOCULAR LENS (IOL), MODEL: AKREOS ADVANCED OPTICS ASPHERIC LENS, AO60. THE DEVICE IS INDICATED FOR PRIMARY IMPLANTATION FOR THE VISUAL CORRECTION OF APHAKIA IN ADULT PATIENTS WHERE A CATARACTOUS LENS HAS BEEN REMOVED BY PHACOEMULSIFI-CATION. THE LENS IS INTENDED TO BE PLACED IN THE CAPSULAR BAG. |
| Approval Order | Approval Order |
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| Summary | Summary of Safety and Effectiveness |
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| Labeling | Labeling
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| Supplements: |
S001 S002 S004 S005 S006 S007 S008 S009 S010 S011 S012
S013 S014 S015 S016 S017 S019 S020 S021 S022 S023 S024 S025
S026 S028 S029 S030 S031 S032 S033 |
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