Ciba Vision Contact Lenses Recalled In UK

Another <"">contact lens recall has just been announced. CIBA Vision is recalling some of its Softperm daily wear contact lenses due to safety concerns that the lenses are not sterile and could lead to eye infections, said Optometry Today.

Every lot manufactured after March 13, 2009 is involved and should be returned to CIBA Vision. In the meantime, said Contact Lenses, an investigation is under way.

It seems that a change to the lens package vial stopper led to CIBA Vision discovering that the lenses’ sterility could have been compromised, according to a release from the Medicines and Healthcare Products Regulatory Agency (MHRA), wrote Optometry Today. The release also explained that the compromised sterility could lead to eye infections, noted Optometry Today.

In addition to sterility issues, the MHRA release noted that the pH of the solution in which the lenses are stored could be “out of specification,” causing eye burning and stinging when the contact lenses are inserted in the eye, wrote Optometry Today.

Optometry Today said that optometrists are being asked to contact their patients who have received the impacted Softperm lots of the contact lenses and ask those patients to return the recalled lenses to the prescribing optometrist.

In England, a medical device alert was sent to NHS trusts and PCTs; in Scotland and Wales, a medical device alert was sent to NHS boards; and in Northern Ireland, a medical device alert was sent to HSC trusts. The so-called trusts have been urged to point out the recall to optometrists, ophthalmologists, ophthalmic nurses, and A&E departments in their area, said Optometry Today.

A CIBA Vision spokesperson told OT: “Softperm supply issues occurred back in June 2010, affecting a small number of our customers. All affected customers were contacted at the time, and Softperm lenses were subsequently discontinued.”

Meanwhile, Bausch + Lomb recalled its ReNu Multi-Purpose Solution and ReNu MultiPlus multi-purpose solution in Europe and the Middle East earlier this year, said Contact Lens. And, this summer, in its ninth recall of the year, Johnson & Johnson recalled millions of its 1 Day Acuvue Contact Lenses, which were sold in Japan and two dozen other countries in Asia and Europe. The recall was extended to include Australia, Germany, France, Russia, the United Kingdom, and Singapore.

The J&J recall initiated in Japan when the pharmaceutical giant advised the Japanese government on August 18th, wrote the Associated Press (AP), which added that J&J did not announce the recall in the U.S.

J&J announced it received complaints from customers in Japan who reported stinging or pain when inserting the Acuvue TruEye Brand Contact Lenses in their eyes, said the AP. Gary Esterow, spokesman for J&J Vision Care Inc., said the firm believes about 100,000 boxes of the 1 Day Acuvue TruEye Brand Contact Lenses, which were manufactured in Ireland, were involved; each box contains 30 or 90 lenses, noted the AP. Esterow said he believed the issue related to equipment failure that occurred when lenses are rinsed during production. It seems a substance used during manufacturing was not removed during the rinse process, explained the AP.

This entry was posted in Defective Medical Devices. Bookmark the permalink.

© 2005-2018 Parker Waichman LLP ®. All Rights Reserved.