ADVISORY - HYDROVIEW IOL LENS - BAUSCH & LOMB

Date: 2001-06-19

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Therapeutic Products Directorate (TPD) and Biologic and Genetic Therapies Directorate (BGTD) posts safety alerts, public health advisories, press releases and other notices from industry as a service to health professionals, consumers, and other interested parties. Although TPD and BGTD approve therapeutic products, TPD and BGTD do not endorse either the product or the company.  Any questions regarding product information should be discussed with your health professional.

This is duplicated text of a letter from Bausch & LombSurgical. Contact the company for a copy of any references, attachments or enclosures.

Bausch & Lomb
Surgical

June 19, 2001

Dear Health Care Provider,

This letter is to notify you that Bausch & Lomb has decided to discontinue sale of the current Hydroview IOL lens product in Canada. Bausch & Lomb intends to apply to Health Canada for a license for the Hydroview IOL lens product packaged with a non-silicone gasket. The new package will retain the same ease of use to which you have grown accustomed.

As you know from our continuing correspondence, there have been reports of calcification developing on the surface of some Hydroview IOL lenses. As previously explained the case of the calcification phenomenon is multi-factorial. One factor which Bausch & Lomb did identify was the potential for silicone compounds from the current SureFold^TM packaging gasket to migrate on to the lens surface. These compounds act as a catalyst for the nucleation of calcium ions onto the surface of the lens, and in the presence of fatty acids, may result in surface calcification. Although more than 99 percent of surgeons have successfully implanted Hydroview without incident, Bausch & Lomb is making a packaging change to eliminate the presence of silicone.

Please report any instances of calcification to Bausch & Lomb at 1-800-387-3284 and to Health Canada at 1-800-267-9675. A Bausch & Lomb representative will be contacting you concerning any unused Hydroview IOL lenses that you may still have in inventory. As always, if you have any questions regarding Hydroview, please contact your local Bausch & Lomb sales representative.

Sincerely,

Doug Friesen
Director, Canadian Operations
Bausch & Lomb Canada Inc.

Any suspected adverse incident can also be reported to:

Health Products & Food Branch Inspectorate
HEALTH CANADA
Address Locator: 3002C
OTTAWA, Ontario, K1A 0K9
Tel: The Medical Devices Hotline 1-800-267-9675