OFFICE USE ONLYAPPLICATION FORM FOR CUSTOM-MADE DEVICES AND MEDICAL DEVICES FOR SPECIAL ACCESS

Return by Facsimile to 1-613-957-1596 or e-mail to sap_devices_mdb@hc-sc.gc.ca.

Please note that all fields must be completed or the application cannot be processed.Health Care Professional Information: (Note: One Application per Health Care Professional)

Name and Title:Provincial Licence Address: Number and Street:

City, Province/Territory: Postal Code:

Telephone Facsimile E-Mail:

Health Care Facility Information

Health Care Facility Name: Address: Number and Street: Same as above

City, Province/Territory: Postal Code:

Date of Procedure TBA

*Additional Facilities can be listed by inserting additional Health Care Facility fields

Information Regarding Unlicensed DeviceName of Device, Components and Accessories: ‘ARTIFICIAL IRIS’

Device Identifier (catalogue or model number):

Artificial Iris (no catalogue or model number assigned)

Quantity of each catalogue or model number required:

3 devices are supplied per procedure. Only one device is implanted while the other two are for back up purposes in case of contamination during surgery. The back- up devices, (if not used) are shipped back to the distributor immediately after surgery.

□ Check this box if this is a custom-made device and provide a copy of the health care professional's written direction to the manufacturer giving the design characteristics of the device.

Manufacturer Information

Manufacturer’s Name: Dr. Schmidt Intarocularlinsen GmbH

Contact Name and Title: Walter Hoffman, Global Product ManagerAddress: Number and Street: 11-13, 53757

City, Province/Territory/State: St. Augustin, Germany Postal Code or ZIP Code:

Telephone: +49 (0) 9131 50665-0 (ext. 76)Facsimile:+49(0)9131 50665-90 E-Mail: Hoffman@humanoptics.com

Importer (Distributor) Information

Name of Importer or Distributor:Surge Canada Medical Inc.

Contact Name and Title: Ross McDonald, President Address: Number and Street:425 Hespeler Rd. Suite 412

City, Province/Territory: Cambridge, Ontario Postal Code:N1R8J6

Telephone: 416-726-1435 Facsimile: 519-622-4317 E-mail:info@surgecanadamedical.com

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□ Check this box if this device is needed for an emergency procedure

Application Form for Custom-Made Devices and Medical Devices for Special Access

Medical Rationale1. Provide the diagnosis, treatment or prevention for which the unlicensed device is requested and the reasons why

this unlicensed device was chosen.

Aniridia due to Traumatic injury. There is no other competitive product available that has a custom fit and creates an identical appearance to the opposite eye.

2. List the licensed devices considered and provide a rationale as to why these licensed devices would not adequately meet the requirements of the patient.

Device Name Medical Device Licence Number 1

Rationale as to why this licensed device would not adequately meet the requirements of the patient There are currently no licensed medical devices available which satisfy the patient’s medical needs

1NOTE: A searchable database of medical devices licensed by Health Canada can be found at: www.mdall.ca

3. Identify and list the risks and benefits associated with the use of the unlicensed device and indicate how the benefits obtained would outweigh the risks.

Risk:

Corneal Damage, inflammation, infection which could lead to loss of eye, , secondary glaucoma

Benefits:

Enhances vision with a natural appearance.

4. Summarize the known safety and effectiveness information in respect of the device.

The Artificial IRIS device has been sold internationally since November of 2002 and has a CE certification – Number

0002.01.22/3. There have been 475 Artificial Irises implanted in 31 countries. Notified body is: mdc medical device certification GmbH (0483). Biocompatibility (in-vitro cytotoxicity) DIN EN ISO 10993-5 – “Artifical Irises are Non cytotoxic with a Grade of 1” There has been (0) zero adverse advents with the product to date.

5. In the case of a request for Batch Release,

(a) describe the emergency condition requiring treatment, and

(b) provide the number of devices required for one month: _________________________

Not applicable as product will not be released as a batch.

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Application Form for Custom-Made Devices and Medical Devices for Special Access

Pursuant to Section 71.(2)(i) of the Medical Devices Regulations, health care professionals are required to make an undertaking that they will inform the patient for whom the device is intended of the risks and benefits associated with its use. Please check the following boxes as appropriate and sign below:

□ I, the Health Care Professional, undertake to inform the patient, , Patient’s Initials or Identifier

who is to be treated with the device of the risks and benefits associated with the use of this unlicensed medical device.

□ I, the Health Care Professional, confirm that I have informed the patient, , Patient’s Initials or Identifier

who is to be diagnosed or treated with the device of the risks and benefits associated with the use of this unlicensed medical device.

In the case of a batch release request

□ I, the Health Care Professional, undertake to inform the patients who are to be treated with the device of the risks and benefits associated with the use of this unlicensed medical device.

□ I, the Health Care Professional, confirm that I cannot inform the patients, who are to be diagnosed or treated with the device of the risks and benefits associated with the use of this unlicensed medical device. I attest that institutional policies will be followed.

Health Care Professional’s Signature and Date:____________________________________________________Signature Date (YYYY-MM-DD)

Notes

1. In the case of a Batch Release, it is the manufacturer or importer’s responsibility to maintain a distribution record in respect of the device in accordance with Sections 52 to 56 of the Medical Devices Regulations.

2. Health care professionals are requested to return any unused devices to the manufacturers or importers.

Declaration

I, the Health Care Professional, certify that the information given is true, correct and complete to the best of my knowledge.

Health Care Professional’s Signature and Date:____________________________________________________Signature Date (YYYY-MM-DD)

Health Care Professional’s Name :____________________________________________________

Return the completed application form with any supporting documentation to the following address by fax or e-mail to:

Special Access Program Medical Devices Bureau Telephone: 1-613-946-8711Health Canada Facsimile: 1-613-957-15962934 Baseline Road, Tower B e-mail: sap_devices_mdb@hc-sc.gc.caAddress Locator 3430AOttawa, Ontario K1A 0K9

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