A

To all affected customers

URGENT: FIELD SAFETY NOTICE

Medical Device Advisory Notice
Date: 23 March 2011 Commercial Name of WaveLight EX500 Excimer Laser Affected Product: FSCA Identifier: JP.T11.8REC.002 Type of Action: Device Modification for the WaveLight EX500 Excimer Laser Attention Health Care Professional: Alcon, as the authorized distributor for WaveLight, is advising you of a Field Safety Corrective Action for the WaveLight EX500 Excimer Laser used in the correction of refractive errors via LASIK surgery. This Device Modification affects all WaveLight EX500 Excimer Laser systems. National Competent Authorities have been advised of this action. Description of the problem: WaveLight has been made aware of discrepancies occurring during the Energy Check calibration that is performed between patients. These discrepancies, which appear to be intermittent, involve the external energy meter displaying an energy reading different from what is being produced by the laser head. This condition would lead the laser electronics to adjust the energy output of the system, subsequently leading to possible overcorrection or undercorrection of the patients eye. Advice on action to be taken by the user: To minimize disruption and to ensure continuous patient care, WaveLight is recommending Health Care Professionals perform a valid Fluence Test in conjunction with every Energy Check. This combination of calibration tests should be performed not only with the daily startup routine, but between each patient as well. As noted in the User Manual, if the measured ablation depth deviates for the target value by more than 3.0 microns (+/- 0.0030 mm), please contact your normal service representative. Alcon is providing additional Fluence Disks (PMMA Plates) for you to perform the additional calibration. Your Alcon Representative will be contacting you in the near future to follow-up on this material and to answer any questions you may have. During that visit, you will be asked to complete the attached Acknowledgement Form.

Transmission of this Field Safety Notice: Please immediately forward this information to professionals within your organization who may be using the WaveLight EX500 Excimer Laser. Additionally, please ensure that a copy of this notification is provided to any other organizations to which the affected devices have been transferred. Contact reference person: We appreciate your immediate attention and cooperation and sincerely regret any inconvenience that this may cause you. We hope this action reassures you of our commitment to provide you with the highest quality vision care products and continued quality excellence for you and your patients. Should you have any questions or concerns about this matter, please do not hesitate to contact me on +44 (0)1442 341171. Yours faithfully,

Tim Cripps Head of Regulatory Affairs UK & Ireland

WaveLight EX500 Device Modification

The Energy Test is recommended between patients (but not earlier than 30 minutes before treatment). This document describes the new energy calibration procedure following the Field Safety Notice
Step 1

Energy Check
This Temporary Energy Test Procedure Manual does not substitute the detailed User Manual. Read the WaveLight EX500 User Manual carefully, because it is more detailed in reference to the device functions.

Press the Energy check- button. Wait for the system to get ready, step on the laser pedal and keep pedal down till message Release foot pedal appears. Energy and laser values are displayed upon completed energy check.

Target Energy: The target energy selected by the user. Ext. Energy: Int. Energy: Laser HV: Shows the measured energy value (WaveLight EX500 will automatically adjust this energy close to the target energy). Shows the actual internal energy value. Shows the actual high voltage value of the laser head in %.

Press Save to complete the test procedure. Successfully passed check is shown by a green progress bar (100%) and the green indicator with date and time.

Step 2

In accordance to the Field Safety Notice, the Fluence Test as described below must be performed at all times after the energy check Fluence Test
Press Fluence Test button and follow the guidance provided in the Info and Warnings box till the Vacuumkey appears.

Device Modification WaveLight EX500 en / Rev.0 / 11-03-16

Page 1 of 2

WaveLight EX500 Device Modification

Verify that test adapter power supply cable is connected to the bed, the green power LED Fan OK is ON and air flows out of the blower opening. Use a PMMA target, peel off plastic foil of the disk and vigorously clean surface.
This Temporary Energy Test Procedure Manual does not substitute the detailed User Manual. Read the WaveLight EX500 User Manual carefully, because it is more detailed in reference to the device functions.

Make sure test adapter is placed in the right direction (as indicated with the above screen)! The air flow of the adapter is directed to intake plume evacuator. Place PMMA in ablation depth meter and press Vacuum. Wait for reading to become stable and press Zero- button. Position PMMA on test adapter and adjust focus to black spot of upper surface (always use a new disk and start with 1). Position PMMA correctly (distance diodes at the center of the artificial pupil) and check pupil tracking (100% on Quality indicator). Press Next and wait until initialization sequence is completed. Step on laser pedal to start ablation and keep laser pedal down till laser stops pulsing and the message Release foot pedal appears. Remove PMMA from test adapter and clean debris moving in one direction away from center of ablation. Insert PMMA into ablation depth meter, start Vacuum and wait for reading to become stable. Measured depth should be 65.0 m +/-1.5 m (permissible range 63.5 66.5 m). Turn off Vacuum to release the PMMA. Note date, depth and your initials on PMMA target and archive the PMMA target. Complete test with Accept- key. Protect probe and close lid.
CORRECT

If ablation depth is not within permissible range of 63.5 66.5 m, press Failed and contact service.

(MM.DD.YYYY)

Customer Name (Please Print)

Date

Customers Signature

Page 2 of 2

Device Modification WaveLight EX500 en / Rev.0 / 11-03-16