Premarket Approval (PMA)

Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.

• Device: TECNIS Synergy Intraocular Lens, TECNIS Synergy Toric II Intraocular Lens, TECNIS Synergy IOL with TECNIS Simplicity Del
• Generic Name: Lens, multifocal intraocular
• Regulation Number: 886.3600
• Applicant: Johnson & Johnson Surgical Vision, Inc.; 31 Technology Drive; Suite 200; Irvine, CA 92618
• PMA Number: P980040
• Supplement Number: S124
• Date Received: 10/02/2020
• Decision Date: 04/28/2021
• Product Code: MFK
• Docket Number: 21M-0421
• Notice Date: 04/30/2021
• Advisory Committee: Ophthalmic
• Supplement Type: Panel Track
• Supplement Reason: Change Design/Components/Specifications/Material
• Expedited Review Granted?: No
• Combination Product: No

Approval Order Statement  
Approval for TECNIS Synergy Intraocular Lens (Model ZFR00V), TECNIS Synergy Toric II Intraocular Lens (Models ZFW150, ZFW225, ZFW300, and ZFW375), TECNIS Synergy IOL with TECNIS Simplicity Delivery System (Model DFR00V), TECNIS Synergy Toric II IOL with TECNIS Simplicity Delivery System (Models DFW150, DFW225, DFW300 and DFW375).The TECNIS Synergy IOL, Model ZFR00V, is indicated for primary implantation for the visual correction of aphakia in adult patients, with less than 1 diopter of pre-existing corneal astigmatism, in whom a cataractous lens has been removed. Compared to an aspheric monofocal lens, the TECNIS Synergy IOL mitigates the effects of presbyopia by providing improved visual acuity at intermediate and near distances to reduce eyeglass wear, while maintaining comparable distance visual acuity. The lens is intended for capsular bag placement only.The TECNIS Synergy Toric II IOL, Models ZFW150, ZFW225, ZFW300, ZFW375, are indicated for primary implantation for the visual correction of aphakia and for the reduction of refractive astigmatism in adult patients with greater than or equal to 1 diopter of preoperative corneal astigmatism, in whom a cataractous lens has been removed. Compared to an aspheric monofocal lens, the TECNIS Synergy Toric II IOLs mitigate the effects of presbyopia by providing improved visual acuity at intermediate and near distances to reduce eyeglass wear, while maintaining comparable distance visual acuity. The lens is intended for capsular bag placement only.The TECNIS Simplicity Delivery System is used to fold and assist in inserting the TECNIS Synergy IOL which is indicated for primary implantation for the visual correction of aphakia in adult patients, with less than 1 diopter of pre-existing corneal astigmatism, in whom a cataractous lens has been removed. Compared to an aspheric monofocal lens, the TECNIS Synergy IOL mitigates the effects of presbyopia by providing improved visual acuity at intermediate and near distances to reduce eyeglass wear, while maintaining comparable distance visual acuity. The lens is intended for capsular bag placement only.The TECNIS Simplicity Delivery System is used to fold and assist in inserting the TECNIS Synergy Toric II IOLs that are indicated for primary implantation for the visual correction of aphakia and for reduction of refractive astigmatism in adult patients with greater than or equal to 1 diopter of preoperative corneal astigmatism, in whom a cataractous lens has been removed. Compared to an aspheric monofocal lens, the TECNIS Synergy Toric II IOLs mitigate the effects of presbyopia by providing improved visual acuity at intermediate and near distances to reduce eyeglass wear, while maintaining comparable distance visual acuity. The lens is intended for capsular bag placement only.

• Approval Order: Approval Order
• Summary: Summary of Safety and Effectiveness
• Labeling: Labeling; Labeling Part 2