PMA P030016S048
- Device
- VISIAN ICL (IMPLANTABLE COLLAMER LENS)
- Applicant
- STAAR Surgical Company
- PMA number
- P030016
- Supplement
- S048
- Product code
- MTA
- Decision date
- 2025-11-14
- Classification
- Ophthalmic
- Generic name
- Lens, intraocular, phakic
- Approval order statement
- approval for expanding the indicated age range from 21-45 years old to 21-60 years old for the EVO/EVO+ ICL/TICL.
Current openFDA PMA Record#
- Device
- VISIAN ICL (IMPLANTABLE COLLAMER LENS)
- Applicant
- STAAR Surgical Company
- PMA number
- P030016
- Supplement
- S048
- Product code
- MTA
- Generic name
- Lens, intraocular, phakic
- Decision date
- 2025-11-14
- Decision code
- APPR
- Date received
- 2025-02-14
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- approval for expanding the indicated age range from 21-45 years old to 21-60 years old for the EVO/EVO+ ICL/TICL.