| 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: |
S015 S005 S006 S001 S002 S004 S007 S026 S013 S028 S031
S032 S033 S024 S025 S019 S030 S029 S034 S008 S009 S010 S014
S021 S017 S023 S016 S020 S022 S011 S012 |
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