The MONARCHTM IIIII IOL Delivery System is a medical device used for implanting foldable intraocular lenses into the eye following removal of the natural crystalline lens.
The system consists of two parts: an autoclavable reusable, titanium handpiece and a sterile single-use cartridge. The handpiece and cartridge are used in conjunction with Alcon qualified intraocular lenses (IOLs) and ophthalmic viscosurgical devices (OVDs) to implant the IOL into the capsular bag.
The manual covers the handpiece, cartridge, and IOL implantation procedures, including cleaning, sterilization, and storage of the handpiece. Additionally, it provides information on the contraindications, warnings, and precautions associated with the use of the MONARCHTM IIIII IOL Delivery System.
Important Notes:
- The handpiece must be cleaned and sterilized prior to the first use and after each subsequent use.
- The use of enzymatic cleaners and detergents is not recommended, but if used, they must be compatible with the materials of construction of the handpiece and be properly rinsed and removed.
- The handpiece must be stored in a protective tray to prevent damage during storage and autoclaving.
Handpiece Precautions
A high level of surgical skill is required for intraocular lens implantation. The surgeon should have observed and/or assisted in numerous implantations and successfully completed one or more courses on intraocular lens implantation before attempting to implant intraocular lenses.
Ordering Information
Contact Alcon Sales Representative with the correct Product Order Number:
Serious Incident Reporting
Any serious incident that may reasonably be regarded as device-related should be reported to Alcon Laboratories, Inc. By Phone: United States Call (800) 757-9780 Website: http://www.alcon.com/contact-us/
Safety and Effectiveness
The MONARCHTM IIIII IOL Delivery System has an acceptable safety and effectiveness profile when used to implant qualified Alcon foldable IOLs. Adverse events rates associated with using the MONARCHTM IIIlI IOL Delivery System are low while clinical outcomes are favorable.
Clinical Features
The MONARCHTM IIIII IOL Delivery System allows for the implantation of Alcon foldable IOLs into the eye following removal of the crystalline lens. The system provides a controlled means to reliably place the Alcon foldable IOL into the capsular bag.
Manual:
Download: Instructions for Use: MONARCHTM IIIII IOL Delivery System
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