CONSTELLATION VISION SYSTEM
FDA 510(k) clearance K141065 · decided 2014-08-22
Clearance details
- K-number
- K141065
- Device name
- CONSTELLATION VISION SYSTEM
- Applicant
- Alcon Research, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2014-04-24
- Decision date
- 2014-08-22
- Days to decision
- 120 days
- Clearance type
- Traditional
- Product code
- HQE
- Device class
- 2
- Regulation number
- 886.4150
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Lake Forest, CA, US
- Third-party review
- No
- Expedited review
- No
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Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
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| UniVit HE, UniVit UHS (K212763) | Visioncare Devices, LLC | 2022-08-10 |
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| VERSAVIT (K121675) | Synergetics, Inc. | 2012-06-21 |
| PROCARE PLUS VITRECTOMY SYSTEM (K120170) | Visioncare Devices, Inc. | 2012-05-30 |
| ULTIMATE VIT ENHAMCER (UVE) (K102222) | Medical Instrument Development Laboratories, Inc. | 2011-04-08 |
| COLIBRI DISPOSABLE VITRECTOMY CUTTER (K033390) | Microworld Medical Instruments, Inc. | 2003-11-04 |
| VMATE MODEL VMM1000 (K030948) | Howard Instruments, Inc. | 2003-06-17 |
| VELOCITY ADVANTAGE (K023939) | Visioncare Devices, Inc. | 2003-04-17 |
| MID LABS AUTONOMOUS VIT ENHANCER (AVE) (K020911) | Medical Instrument Development Laboratories, Inc. | 2002-04-29 |
| D.O.R.C. HARMONY TOTAL TTC VITRECTOMY SYSTEM (K010082) | Dutch Ophthalmic USA, Inc. | 2001-03-12 |
| VIT ENHANCER (K992943) | Medical Instrument Development Laboratories, Inc. | 1999-12-10 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Brand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Unity and Constel recall (Z-0304-2026) | Alcon Research LLC | 2025-10-24 |
| Brand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Unity and Constel recall (Z-0305-2026) | Alcon Research LLC | 2025-10-24 |
| Brand Name: Alcon Laboratories, Inc. Product Name: Constellation Vision System Vitrectomy recall (Z-2108-2025) | Alcon Research LLC | 2025-07-10 |
| Brand Name: Alcon Laboratories, Inc. Product Name: Constellation Vision System Combined Pr recall (Z-2109-2025) | Alcon Research LLC | 2025-07-10 |
| Constellation Vision System, REF: 8065751150 recall (Z-0099-2024) | Alcon Research, LLC | 2023-10-11 |
| Constellation Procedure Pak recall (Z-2406-2023) | Alcon Research, LTD. | 2023-08-16 |
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| AcrySof IQ ReSTOR Posterior Chamber Intraocular Lenses (P040020/S117) | Alcon Research, Ltd. | 2025-12-12 |
| PROVISC Ophthalmic Viscosurgical Device (P890047/S069) | Alcon Research, Ltd. | 2025-10-03 |
| AcrySof® IQ ReSTOR® Posterior Chamber Intraocular Lenses (P040020/S116) | Alcon Research, Ltd. | 2025-09-18 |
| AcrySof® IQ ReSTOR® Posterior Chamber Intraocular Lenses\s (P040020/S115) | Alcon Research, Ltd. | 2025-08-25 |
| PROVISC Ophthalmic Viscosurgical Device (P890047/S068) | Alcon Research, Ltd. | 2025-07-25 |
| AcrySof IQ ReSTOR Posterior Chamber Intraocular Lenses (P040020/S111) | Alcon Research, Ltd. | 2025-06-18 |
| PROVSIC Ophthalmic Viscosurgical Device (P890047/S067) | Alcon Research, Ltd. | 2025-02-26 |
| AcrySof ReSTOR Posterior Chamber Intraocular Lens (IOL) (P040020/S113) | Alcon Research, Ltd. | 2025-02-14 |