The FDA and European regulatory agencies have approved the return of CIBA Vision's MemoryLens to the marketplace after the product was voluntarily withdrawn in April.

MemoryLens is the only pre-folded intraocular lens used in a procedure to restore vision to cataract patients.

It was pulled from the market in response to reports of inflammatory reactions caused by traces of a polishing compound left on the lens during the manufacturing process. The company says these inflammatory reactions occurred in only one-tenth of 1% of the patients who received the implants.

CIBA Vision says it has made a number of manufacturing modifications to eliminate the defect, while also working closely with the FDA and European regulatory authorities. The company plans a controlled relaunch of MemoryLens, first in Europe and then in the United States.

MemoryLens was originally manufactured by Mentor Corp and had been sold in Europe since 1995. It received FDA approval in late 1997. CIBA Vision acquired Mentor's entire line of intraocular products in July 1999.