Product code MTA
- Device name
- Lens, Intraocular, Phakic
- Medical specialty
- Unknown
- Device class
- 3
- Review panel
- OP
- Implant
- Y
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Ineligible
- Source
- FDA openFDA device classification dataset
Related PMA Records#
| PMA | Device | Applicant | Decision date |
|---|---|---|---|
| P030028S013 | ARTISAN Myopia Models 204US1W and 206US1W | Ophtec BV | 2026-04-24 |
| P030016S051 | The EVO/EVO+ Visian Implantable Collamer Lens (ICL) | STAAR Surgical Company | 2026-03-04 |
| P030016S048 | VISIAN ICL (IMPLANTABLE COLLAMER LENS) | STAAR Surgical Company | 2025-11-14 |
| P030016S047 | EVO Visian Implantable Collamer Lens for Myopia (VICMO), EVO Visian Toric Implantable Collamer Lens for Myopia (VTICMO), | STAAR Surgical Company | 2025-03-05 |
| P030028S010 | Artisan Myopia | Ophtec BV | 2024-11-15 |
| P030016S045 | EVO Visian Implantable Collamer Lens for Myopia (VICMO), EVO Visian Toric Implantable Collamer Lens for Myopia (VTICMO), | STAAR Surgical Company | 2024-10-01 |
| P030016S046 | Visian ICL (Implantable Collamer Lens), Visian Toric ICL (Implantable Collamer Lens), Visian EVO/EVO+ ICL (Implantable C | STAAR Surgical Company | 2024-05-10 |
| P030028S012 | ARTISAN Phakic lntraocular Lens (IOL), | Ophtec BV | 2024-01-18 |
| P030028S009 | Artisan Myopia | Ophtec BV | 2022-07-22 |
| P030016S042 | EVO/EVO+ VISIAN® Implantable Collamer® Lenses | STAAR Surgical Company | 2022-05-20 |
| P030016S043 | EVO/EVO+ VISIAN® Implantable Collamer® Lenses | STAAR Surgical Company | 2022-05-04 |
| P030016S035 | EVO/EVO+VISIAN Implantable Collamer Lens | STAAR Surgical Company | 2022-03-25 |
| P030016S041 | Visian Implantable Collamer Lens (ICL) | STAAR Surgical Company | 2021-07-19 |
| P030016S040 | Visian Implantable Collamer Lens | STAAR Surgical Company | 2020-03-31 |
| P030016S039 | Visian Implantable Collamer Lens | STAAR Surgical Company | 2019-07-26 |
| P030016S038 | Visian Toric ICL (Implantable Collamer Lens) | STAAR Surgical Company | 2019-07-19 |
| P030016S037 | Visian ICL Implantable Collamer Lens (ICL) | STAAR Surgical Company | 2019-07-19 |
| P030028S008 | Artisan Myopia Intraocular Lens | Ophtec BV | 2019-05-14 |
| P030016S036 | Visian ICL (Implantable Collamer Lens) | STAAR Surgical Company | 2019-04-15 |
| P030016S034 | Visian Toric ICL (IMPLANTABLE COLLAMER LENS) | STAAR Surgical Company | 2019-03-07 |
| P030028S006 | Artisan Myopia | Ophtec BV | 2018-10-23 |
| P030028S005 | ARTISAN/VERISYSE MYOPIA PHAKIC INTRAOCULAR LENS | Ophtec BV | 2018-08-20 |
| P030028S004 | ARTISAN/Verisyse Myopia Phakic Intraocular Lens (IOL) | Ophtec BV | 2018-08-20 |
| P030016S033 | Visian Implantable Collamer Lens for Myopia | STAAR Surgical Company | 2017-08-04 |
| P030016S032 | Visian Implantable Collamer Lens for Myopia | STAAR Surgical Company | 2017-07-20 |
| P030016S031 | Visian Implantable Collamer Lens for Myopia | STAAR Surgical Company | 2017-06-16 |
| P030016S022 | STAAR SURGICAL IMPLANTABLE COLLAMER LENS (VISION ICL) | STAAR Surgical Company | 2017-03-08 |
| P030016S030 | VISIAN ICL (IMPLANTABLE COLLAMER LENS) FOR MYOPIA | STAAR Surgical Company | 2017-01-25 |
| P030016S029 | VISIAN IMPLANTABLE COLLAMER LENS FOR MYOPIA (MICL) | STAAR Surgical Company | 2015-12-10 |
| P030016S028 | VISIAN IMPLANTABLE COLLAMER LENS FOR MYOPIA (MICL) | STAAR Surgical Company | 2015-11-17 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00840311300600 | EVO/EVO+VISIAN Implantable Collamer Lens | STAAR SURGICAL COMPANY | 2023-11-30 |
| 00840311300914 | EVO/EVO+VISIAN Implantable Collamer Lens | STAAR SURGICAL COMPANY | 2023-11-30 |
| 00840311300907 | EVO/EVO+VISIAN Implantable Collamer Lens | STAAR SURGICAL COMPANY | 2023-11-30 |
| 00840311300891 | EVO/EVO+VISIAN Implantable Collamer Lens | STAAR SURGICAL COMPANY | 2023-11-30 |
| 00840311300846 | EVO/EVO+VISIAN Implantable Collamer Lens | STAAR SURGICAL COMPANY | 2023-11-30 |
| 00840311300822 | EVO/EVO+VISIAN Implantable Collamer Lens | STAAR SURGICAL COMPANY | 2023-11-30 |
| 00840311300815 | EVO/EVO+VISIAN Implantable Collamer Lens | STAAR SURGICAL COMPANY | 2023-11-30 |
| 00840311300808 | EVO/EVO+VISIAN Implantable Collamer Lens | STAAR SURGICAL COMPANY | 2023-11-30 |
| 00840311300686 | EVO/EVO+VISIAN Implantable Collamer Lens | STAAR SURGICAL COMPANY | 2023-11-30 |
| 00840311300679 | EVO/EVO+VISIAN Implantable Collamer Lens | STAAR SURGICAL COMPANY | 2023-11-30 |
| 00840311300662 | EVO/EVO+VISIAN Implantable Collamer Lens | STAAR SURGICAL COMPANY | 2023-11-30 |
| 00840311300655 | EVO/EVO+VISIAN Implantable Collamer Lens | STAAR SURGICAL COMPANY | 2023-11-30 |
| 00840311300648 | EVO/EVO+VISIAN Implantable Collamer Lens | STAAR SURGICAL COMPANY | 2023-11-30 |
| 00840311300631 | EVO/EVO+VISIAN Implantable Collamer Lens | STAAR SURGICAL COMPANY | 2023-11-30 |
| 00840311300624 | EVO/EVO+VISIAN Implantable Collamer Lens | STAAR SURGICAL COMPANY | 2023-11-30 |
| 00840311300594 | EVO/EVO+VISIAN Implantable Collamer Lens | STAAR SURGICAL COMPANY | 2023-11-30 |
| 00840311300587 | EVO/EVO+VISIAN Implantable Collamer Lens | STAAR SURGICAL COMPANY | 2023-11-30 |
| 00840311300532 | EVO/EVO+VISIAN Implantable Collamer Lens | STAAR SURGICAL COMPANY | 2023-11-30 |
| 00840311300525 | EVO/EVO+VISIAN Implantable Collamer Lens | STAAR SURGICAL COMPANY | 2023-11-30 |
| 00840311300518 | EVO/EVO+VISIAN Implantable Collamer Lens | STAAR SURGICAL COMPANY | 2023-11-30 |
| 00840311300303 | EVO/EVO+VISIAN Implantable Collamer Lens | STAAR SURGICAL COMPANY | 2023-11-30 |
| 00840311300297 | EVO/EVO+VISIAN Implantable Collamer Lens | STAAR SURGICAL COMPANY | 2023-11-30 |
| 00840311300235 | EVO/EVO+VISIAN Implantable Collamer Lens | STAAR SURGICAL COMPANY | 2023-11-30 |
| 00840311300228 | EVO/EVO+VISIAN Implantable Collamer Lens | STAAR SURGICAL COMPANY | 2023-11-30 |
| 00840311300181 | EVO/EVO+VISIAN Implantable Collamer Lens | STAAR SURGICAL COMPANY | 2023-11-30 |
| 00840311300174 | EVO/EVO+VISIAN Implantable Collamer Lens | STAAR SURGICAL COMPANY | 2023-11-30 |
| 00840311300167 | EVO/EVO+VISIAN Implantable Collamer Lens | STAAR SURGICAL COMPANY | 2023-11-30 |
| 00840311300150 | EVO/EVO+VISIAN Implantable Collamer Lens | STAAR SURGICAL COMPANY | 2023-11-30 |
| 00840311300143 | EVO/EVO+VISIAN Implantable Collamer Lens | STAAR SURGICAL COMPANY | 2023-11-30 |
| D6620703523022 | Patterson® | PATTERSON DENTAL SUPPLY, INC. | 2016-09-23 |