Phakic Toric Intraocular Lens
FDA product code QCB · Class III (high risk) · 21 CFR 886.3600 · Ophthalmic
Intended to be implanted within the eye to optically correct astigmatism (with or without other refractive errors), without removing the natural crystalline lens.
0510(k) clearances
0PMA approvals
5recalls
Implantimplanted device
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1480-2026 Class II | EVO+ Visian Toric Implantable Collamer Lens (TICL), Model: VTICM5Toric Implantable Collamer for correction/reduction of myopia in phakic eyes with astigmatism were labeled… | Staar Surgical AG | 01/21/2026Open, Classified |
| Z-0473-2024 Class II | EVO+VISIAN Implantable Collamer Lens, REF:VTICM5_13.7. Phakic Toric Intraocular lens.Their is a potential that intraocular implant devices may not meet specifications. | Staar Surgical Company | 09/29/2023Open, Classified |
| Z-0472-2024 Class II | EVO+VISIAN Implantable Collamer Lens, REF: VTICM5_13.2. Phakic Toric Intraocular lens.Their is a potential that intraocular implant devices may not meet specifications. | Staar Surgical Company | 09/29/2023Open, Classified |
| Z-0471-2024 Class II | EVO+VISIAN Implantable Collamer Lens, REF: VTICM5_12.6. Phakic Toric Intraocular lens.Their is a potential that intraocular implant devices may not meet specifications. | Staar Surgical Company | 09/29/2023Open, Classified |
| Z-0470-2024 Class II | EVO+VISIAN Implantable Collamer Lens, REF: VTICM5_12.1. Phakic Toric Intraocular lens.Their is a potential that intraocular implant devices may not meet specifications. | Staar Surgical Company | 09/29/2023Open, Classified |