CONSTELLATION® Vision System Brief Statement
Indications for Use:
The CONSTELLATION
® VISION SYSTEM is an ophthalmic microsurgical system that is indicated for both anterior segment (i.e., phacoemulsification and removal of cataracts) and posterior segment (i.e., vitreoretinal) ophthalmic surgery.
Caution: Federal (USA) law restricts this device to sale by, or on the order of, a physician.
Warnings and Precautions:
- The disposables used in conjunction with Alcon instrument products constitute a complete surgical system. Use of disposables and handpieces other than those manufactured by Alcon may affect system performance and create potential hazards.
- Attach only Alcon supplied consumables to console and cassette luer fittings. Do not connect consumables to the patient's intravenous connections.
- Mismatch of consumable components and use of settings not specifically adjusted for a particular combination of consumable components may create a patient hazard.
- Vitreous traction has been known to create retinal tears and retinal detachments.
- The closed loop system of the CONSTELLATION® VISION SYSTEM that adjusts IOP cannot replace the standard of care in judging IOP intraoperatively. If the surgeon believes that the IOP is not responding to the system settings and is dangerously high, this may represent a system failure. Note: To ensure proper IOP Compensation calibration, place infusion tubing and infusion cannula on a sterile draped tray at mid-cassette level during the priming cycle.
- Leaking sclerotomy may lead to post operative hypotony.
Important Safety Information: Warnings and Cautions: A complete listing is available in the CONSTELLATION
® VISION SYSTEM Operators Manual. To obtain a copy, please contact Alcon Customer Service.
