# P030016: Visian Icl (Implantable Collamer Lens)

- Pathway: PMA
- Applicant: STAAR Surgical Company
- Decided: Dec 22, 2005 after 959 days
- Product code: MTA (Lens, Intraocular, Phakic)
- Device class: 3
- Recalls of this device: 8 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. PMA decisions do not claim a predicate device.

## Recalls of this device
- Jan 21, 2026 · Class II · Z-1480-2026: Toric Implantable Collamer for correction/reduction of myopia in phakic eyes with astigmatism were labeled as 12.1 mm length but are 12.6 mm length lenses, so there is the potential for excessive vaul
- Sep 29, 2023 · Class II · Z-0464-2024: Their is a potential that intraocular implant devices may not meet specifications.
- Sep 29, 2023 · Class II · Z-0465-2024: Their is a potential that intraocular implant devices may not meet specifications.
- Sep 29, 2023 · Class II · Z-0466-2024: Their is a potential that intraocular implant devices may not meet specifications.
- Sep 29, 2023 · Class II · Z-0467-2024: Their is a potential that intraocular implant devices may not meet specifications.
- Sep 29, 2023 · Class II · Z-0469-2024: Their is a potential that intraocular implant devices may not meet specifications.
- Sep 29, 2023 · Class II · Z-0474-2024: Their is a potential that intraocular implant devices may not meet specifications.
- Sep 29, 2023 · Class II · Z-0468-2024: Their is a potential that intraocular implant devices may not meet specifications.

Source page: https://510kreport.com/device/P030016
Methodology: https://510kreport.com/methodology