TECNIS TORIC 1-PEICE INTRAOCULAR LENS
FDA premarket approval P980040/S039 · decided 2013-04-15
Approval details
- PMA number
- P980040
- Supplement
- S039
- Supplement type
- Panel Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- TECNIS TORIC 1-PEICE INTRAOCULAR LENS
- Generic name
- LENS, INTRAOCULAR, TORIC OPTICS
- Applicant
- Johnson & Johnson Surgical Vision, Inc.
- Date received
- 2012-04-09
- Decision date
- 2013-04-15
- Days to decision
- 371 days
- Decision code
- APPR
- Product code
- MJP
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Irvine, CA
- 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 DI
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