- Device
- TECNIS Eyhance IOL, TECNIS Eyhance IOL with SmartLOAD Delivery Technology, TECNIS Eyhance IOL with TECNIS Simplicity Del
- Applicant
- Johnson & Johnson Surgical Vision, Inc.
- PMA number
- P980040
- Supplement
- S117
- Product code
- HQL
- Generic name
- intraocular lens
- Decision date
- 2020-12-29
- Decision code
- APPR
- Date received
- 2020-06-15
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- TECNIS EyhanceTM IOL, Model ICB00; TECNIS EyhanceTM IOL with SmartLOADTM Delivery Technology, Model GIB00; TECNIS EyhanceTM IOL with TECNIS SimplicityTM Delivery System, Model DIB00; TECNIS EyhanceTM Toric II IOLs, Models ICU150-600; and TECNIS EyhanceTM Toric II IOLs with TECNIS SimplicityTM Delivery System, Models DIU150-600, which are an extension of the TECNIS family of one-piece IOLs that incorporate an optical modification.