Description:

Single Use Injector System are used for injecting the foldable intraocular lenses into the eye during cataract surgery.

Important Notice:

This product is a medical device. The package contains one sterile Single Use Injector System. It is highly recommended that the surgeon adheres to the instructions and warnings outlined in this Instructions For Use (IFU).

Indications:

Single Use Injector is intended for use in insertion of hydrophilic and hydrophobic intraocular lens during phacoemulsification cataract surgery.

Limitations:

· Forcing an implant through an inadequate incision results in trauma of the wound potentially causing an inability to self- seal.

Premature release of the implant with subsequent ocular injury and or damage to the implant.

· Folding and compression of the lens should be done prior to insertion and delivery. Failure to follow the instructions for use may result in patient injury.

· Injectors cannot be reused, as they are not designed to perform as intended after first and only usage. Changes in mechanical, physical or chemical characteristics, under conditions of repeated use, cleaning and resterilisation will compromise the integrity of injectors.

Re-use could lead to illness, infection and/or injury or in extreme incidents to the patient.

· Do not resterilise.

· Do not reuse. Single use only.

· Contents are sterile. Do not use if the sterile barrier system or packaging is opened or damaged.

· Do not use after expiry date.

· Discontinue lens delivery if excessive force is needed to advance the plunger and lens.

· Retain exterior packaging until enclosed device is  used.

· Do not store Injector in direct sunlight or at temperatures below  freezing.

· Discard the device if the labels and IFUs are with unclear or wrong information.

· 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 lens.

· In case of serious incident occurred in relation to OriMed products, patients or surgeons shall report the case with details to Oriental Medical Devices Inc. and the competent authority.

NOTE:

Please dispose the injector and cartridge after the lens implantation.

Any form of change to the IOL injector is prohibited.

The IOL should not be placed in the folder for more than one minute.

Storage Conditions:

Keep away from sunlight.

Store at temperature between 5℃ – 25℃

Package:

Single use injector system is supplied individually packaged in sterilized pouch and outside package.

Note: Do not use if sterile pouch is opened or damaged