PMA P980040S039
- Device
- TECNIS TORIC 1-PEICE INTRAOCULAR LENS
- Applicant
- Johnson & Johnson Surgical Vision, Inc.
- PMA number
- P980040
- Supplement
- S039
- Product code
- MJP
- Decision date
- 2013-04-15
- Classification
- Lens, Intraocular, Toric Optics
- Generic name
- LENS, INTRAOCULAR, TORIC OPTICS
- Approval order statement
- APPROVAL OF THE TECNJS® TORIC 1-PIECE IOL, MODELS ZCT150, ZCT225, ZCT300 AND ZCT400, AND THE TECNIS® TORIC CALCULATOR SYSTEM. THIS DEVICE IS INDICATED FOR THE VISUAL CORRECTION OF APHAKIA AND PRE-EXISTING CORNEAL ASTIGMATISM OF ONE DIOPTER OR GREATER IN ADULT PATIENTS WITH OR WITHOUT PRESBYOPIA IN WHOM A CATARACTOUS LENS HAS BEEN REMOVED BY PHACOEMULSIFICATION AND WHO DESIRE IMPROVED UNCORRECTED DISTANCE VISION, REDUCTION IN RESIDUAL REFRACTIVE CYLINDER AND INCREASEDSPECTACLE INDEPENDENCE FOR DISTANCE VISION. THE DEVICE IS INTENDED TO BE PLACED IN THE CAPSULAR BAG.
- Summary
- <a href="http://www.accessdata.fda.gov/cdrh_docs/pdf/P980040S039B.pdf" target="_new">Summary of Safety and Effectiveness</a>
Current openFDA PMA Record#
- Device
- TECNIS TORIC 1-PEICE INTRAOCULAR LENS
- Applicant
- Johnson & Johnson Surgical Vision, Inc.
- PMA number
- P980040
- Supplement
- S039
- Product code
- MJP
- Generic name
- LENS, INTRAOCULAR, TORIC OPTICS
- Decision date
- 2013-04-15
- Decision code
- APPR
- Date received
- 2012-04-09
- Supplement type
- Panel Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL OF THE TECNJS® TORIC 1-PIECE IOL, MODELS ZCT150, ZCT225, ZCT300 AND ZCT400, AND THE TECNIS® TORIC CALCULATOR SYSTEM. THIS DEVICE IS INDICATED FOR THE VISUAL CORRECTION OF APHAKIA AND PRE-EXISTING CORNEAL ASTIGMATISM OF ONE DIOPTER OR GREATER IN ADULT PATIENTS WITH OR WITHOUT PRESBYOPIA IN WHOM A CATARACTOUS LENS HAS BEEN REMOVED BY PHACOEMULSIFICATION AND WHO DESIRE IMPROVED UNCORRECTED DISTANCE VISION, REDUCTION IN RESIDUAL REFRACTIVE CYLINDER AND INCREASEDSPECTACLE INDEPENDENCE FOR DISTANCE VISION. THE DEVICE IS INTENDED TO BE PLACED IN THE CAPSULAR BAG.