The CLAREONTM MONARCHTM IV IOL Delivery System is a medical device designed to implant foldable intraocular lenses into the eye following removal of the natural crystalline lens.
Key Features
The system consists of two parts: an autoclavable, reusable, titanium handpiece and a sterile, single-use cartridge.
The handpiece is non-sterile and must be cleaned and sterilized prior to each use to prevent serious infection.
Indications and Contraindications
The CLAREON MONARCH TM IV IOL Delivery System is intended for use by a trained ophthalmic staff to implant Alcon qualified foldable IOLs into the eye following removal of the natural crystalline lens.
There are no known contraindications to the use of the CLAREON MONARCH TM IV IOL Delivery System when used as recommended.
Warnings and Precautions
Complications with the CLAREON MONARCH TM IV IOL Delivery System used in conjunction with cataract surgery and IOL implantation include physical injury, postoperative inflammation, prion infection, toxic reactions, irritation, corneal endothelial cell damage, infection, retinal detachment, corneal edema, pigment dispersion, tissue damage, decreased or blurred vision, unexpected postoperative refraction, visual disturbance, IOL decentration, tilt or dislocation, and elevated IOP.
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.
Performance Characteristics
An evaluation of postmarket surveillance, clinical investigations, and clinical literature data support that the MONARCH TM III II IOL Delivery System has an acceptable safety and performance profile when used to implant qualified Alcon foldable IOLs.
Adverse events rates associated with using the MONARCH TM III II IOL Delivery System are low while clinical outcomes are favorable.
Clinical Features
The CLAREON MONARCH TM IV IOL Delivery System allows for the implantation of qualified Alcon foldable IOLs into the eye following removal of the crystalline lens.
The system provides a controlled means to reliably place the qualified Alcon foldable IOL into the capsular bag.
Manual:
Download: INSTRUCTIONS FOR USE CLAREONTM MONARCHTM IV IOL DELIVERY SYSTEM
Chat: Powered By VoiceSphere