PMA P240038

Device: FINEVISION HP Trifocal IOLs
Applicant: Beaver Visitec International, Inc.
Product code: HQL
Decision date: 2026-09-25
Generic name: intraocular lens
Approval order statement: approval for an extension of the device shelf life from 3 years to 5 years, and expanded storage condition range to 2-35°C, for the FINEVISION HP Trifocal intraocular lens.

Current openFDA PMA Record#

Device: FINEVISION HP Trifocal IOLs
Applicant: Beaver Visitec International, Inc.
PMA number: P240038
Supplement: S003
Product code: HQL
Generic name: intraocular lens
Decision date: 2026-09-25
Decision code: APPR
Date received: 2026-07-01
Supplement type: Real-Time Process
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: approval for an extension of the device shelf life from 3 years to 5 years, and expanded storage condition range to 2-35°C, for the FINEVISION HP Trifocal intraocular lens.