PMA P240038
- Device
- FINEVISION HP Trifocal IOLs
- Applicant
- Beaver Visitec International, Inc.
- Product code
- HQL
- Decision date
- 2025-09-10
- Generic name
- intraocular lens
- Approval order statement
- Approval for the FINEVISION HP Trifocal Intraocular Lens (IOL). The FlNEVISION HP Trifocal intraocular Lens is indicated for primary implantation in the capsular bag in the posterior chamber of the eye 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 by phacoemulsification. The lens mitigates the effects of presbyopia by providing improved intermediate and near visual acuity, while maintaining comparable distance visual acuity compared to a monofocal IOL.
Current openFDA PMA Record#
- Device
- FINEVISION HP Trifocal IOLs
- Applicant
- Beaver Visitec International, Inc.
- PMA number
- P240038
- Product code
- HQL
- Generic name
- intraocular lens
- Decision date
- 2025-09-10
- Decision code
- APPR
- Date received
- 2024-10-30
- Approval order statement
- Approval for the FINEVISION HP Trifocal Intraocular Lens (IOL). The FlNEVISION HP Trifocal intraocular Lens is indicated for primary implantation in the capsular bag in the posterior chamber of the eye 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 by phacoemulsification. The lens mitigates the effects of presbyopia by providing improved intermediate and near visual acuity, while maintaining comparable distance visual acuity compared to a monofocal IOL.