PMA P980040S049
- Device
- TECNIS MULTIFOCAL 1-PIECE INTRAOCULAR LENS (IOL)
- Applicant
- Johnson & Johnson Surgical Vision, Inc.
- PMA number
- P980040
- Supplement
- S049
- Product code
- MFK
- Decision date
- 2014-12-17
- Classification
- Lens, Multifocal Intraocular
- Generic name
- Lens, multifocal intraocular
- Approval order statement
- APPROVAL FOR THE TECNIS® MULTIFOCAL 1-PIECE INTRAOCULAR LENS, MODELS ZKB00 AND ZLB00. THIS DEVICE IS INDICATED FOR PRIMARY IMPLANTATION FOR THE VISUAL CORRECTION OF APHAKIA IN ADULT PATIENTS WITH ANDWITHOUT PRESBYOPIA IN WHOM A CATARACTOUS LENS HAS BEEN REMOVED BY PHACOEMULSIFICATION AND WHO DESIRE NEAR, INTERMEDIATE, AND DISTANCE VISION WITH INCREASED SPECTACLE INDEPENDENCE. THEINTRAOCULAR LENSES ARE INTENDED TO BE PLACED IN THE CAPSULAR BAG.
- Summary
- <a href="http://www.accessdata.fda.gov/cdrh_docs/pdf/P980040S049B.pdf" target="_new">Summary of Safety and Effectiveness</a>
Current openFDA PMA Record#
- Device
- TECNIS MULTIFOCAL 1-PIECE INTRAOCULAR LENS (IOL)
- Applicant
- Johnson & Johnson Surgical Vision, Inc.
- PMA number
- P980040
- Supplement
- S049
- Product code
- MFK
- Generic name
- Lens, multifocal intraocular
- Decision date
- 2014-12-17
- Decision code
- APPR
- Date received
- 2014-06-30
- Supplement type
- Panel Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR THE TECNIS® MULTIFOCAL 1-PIECE INTRAOCULAR LENS, MODELS ZKB00 AND ZLB00. THIS DEVICE IS INDICATED FOR PRIMARY IMPLANTATION FOR THE VISUAL CORRECTION OF APHAKIA IN ADULT PATIENTS WITH ANDWITHOUT PRESBYOPIA IN WHOM A CATARACTOUS LENS HAS BEEN REMOVED BY PHACOEMULSIFICATION AND WHO DESIRE NEAR, INTERMEDIATE, AND DISTANCE VISION WITH INCREASED SPECTACLE INDEPENDENCE. THEINTRAOCULAR LENSES ARE INTENDED TO BE PLACED IN THE CAPSULAR BAG.