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MemoryLens is back on the U.S., European markets
The FDA and European regulatory authorities granted approval for CIBA Vision to re-introduce the MemoryLens.
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ATLANTA - After nearly 6 months out of use, CIBA Vision's MemoryLens is being implanted again in the United States and Europe. CIBA Vision announced that it had received approval from both the Food and Drug Administration (FDA) and the European regulatory authorities to return its MemoryLens product to market.
The MemoryLens is the only pre-folded intraocular lens in the world used to restore vision in patients with cataracts.
CIBA Vision voluntarily withdrew the lens from the global market in April 2000 to enhance the manufacturing process. It was discovered that traces of a polishing compound on the lens were the cause of a minimal number of inflammatory reactions. CIBA Vision officials claim that 0.1% of the lenses showed traces of contamination.
The reactions reported consisted of mild to, in some cases, more severe inflammation appearing 3 to 5 days after surgery. All cases responded well to topical treatment with antibiotics and anti-inflammatories.
CIBA Vision investigated the cases of inflammation and enhanced its manufacturing process. After the company made the changes, fewer cases of inflammation were reported, but CIBA Vision continued to see isolated incidents. So the company withdrew the entire remaining inventory from the marketplace.
David Bailey, president of CIBA Vision's Surgical Business Unit, stated in a press release that the company had "made a number of manufacturing modifications - all focused on enhancing our product - a product that many expert surgeons say is the 'quietest intraocular lens material in the eye.' "
He went on to explain that CIBA Vision conducted a controlled re-launch of the product in Europe and then in the U.S. The thought behind the phased re-launch was to prove the "quietness" of the lens.
Mr. Bailey also stated that CIBA Vision worked closely with the FDA and European regulatory authorities during the process.
The MemoryLens has been sold in Europe since the fall of 1995. The FDA approved it in December 1997.
California-based Mentor Corp. originally sold the MemoryLens. CIBA Vision acquired Mentor's entire line of intraocular lens products, including the MemoryLens, in July 1999.
According to CIBA Vision officials, MemoryLens does not require complicated injectors or special forceps to insert the lens in the eye during surgery because it is prefilled for one-step cataract surgery. CIBA Vision indicated that this one-step process gives surgeons more control and saves time with each implant. The lens' uniplanar haptics are designed to provide a consistent, gentle unfolding and centering of the lens in the pupil.
Improvements
During the 2000 annual meeting of the European Society of Cataract and Refractive Surgery (ESCRS) in Brussels, Belgium, Douglas Katsev, MD, of Santa Barbara, Calif., announced that CIBA Vision was reintroducing the lens and that he would be implanting his first MemoryLens when he returned to his practice after the conference. In October, Dr. Katsev had implanted 50 patients with the new lens, including his father.
Dr. Katsev, who has used the MemoryLens since early 1998, stated that he never had any complications with the lens. He also suspected the problem might have been center specific and possibly unrelated to the MemoryLens.
In his address to ESCRS, he also said that the company would soon be announcing other significant improvements to the lens design.
For example, the lens will be rolled tighter, which will thus allow the lens to be inserted in through a 3-mm incision. Dr. Katsev said that the lens might even be able to be inserted through an incision as small as 2.8 mm.
For Your Information:
- David Bailey can be reached at CIBA Vision, 11460 Johns Creek Parkway, Duluth, GA 30097; (678) 415-3646; fax (678) 415-3592; http://www.cibavision.com.
- Doug Katsev, MD can be reached at 29 West Anapmu, Santa Barbara, CA 93101; (805) 681-8950; fax: (805) 568-1933; e-mail: katsev@aol.com.