MemoryLens voluntarily recalled due to inflammation

CIBA Vision enhances its manufacturing process and plans to introduce a more tightly rolled MemoryLens as soon as September.

Issue: June 1, 2000

DULUTH, Ga. — CIBA Vision’s surgical business unit voluntarily recalled its MemoryLens U940A and U940S models from global markets recently after concluding the aluminum oxide used to polish the lens could have caused postoperative inflammation.

David Bailey, president of CIBA Vision’s surgical business unit, said “It’s well documented that this inert material can be associated with this type of reaction, and although not conclusive, all other reasonable possibilities have been excluded from our investigation.”

The reactions reported consisted of mild to, in some cases, more severe inflammation appearing three to five days after surgery, Mr. Bailey said. All cases responded well to topical treatment with antibiotics and anti-inflammatories.

The inflammatory reaction was found in less than 0.1% of patients receiving these lenses. This rate includes all reports of similar adverse events, including those that the reporting physicians and hospitals attributed to factors other than the lens.

“The issue really was in isolating the exact nature of the reaction and establishing whether it was related to our manufacturing process,” Mr. Bailey said. “This type of reaction can often be multi-factorial in nature.”

Incidence rate

Postoperative inflammation was less than one-third of the reaction rate reported in the clinical trials used to receive regulatory approval of the MemoryLens, according to a corporate statement.

“CIBA Vision takes all such reports extremely seriously and acted immediately to follow up on all reports and to vigorously investigate all potential causes of these incidents,” the statement read. “The fact that these occurrences were infrequent and may be caused by a number of factors made it difficult to reach a rapid conclusion as to a single cause. It therefore took time to understand and assess all possible causes before reaching any conclusions.”

Hypopyon and endophthalmitis were reported, although no one reaction could be directly attributed to the lens.

Timeline of events

CIBA Vision had bought the MemoryLens line from Mentor Corporation in July of last year. Physicians reported an increasing incidence of inflammation in late 1999 in lenses made the same way that Mentor had made the lenses.

Few reports of inflammation existed before the sale, Mr. Bailey said. The manufacturing process had not changed in the sale, he added.

CIBA Vision investigated the inflammation and enhanced its manufacturing process. After the company made the changes, fewer cases of inflammation were reported, but the company continued to see isolated incidents. So the company withdrew all the remaining inventory from the marketplace.

According to a corporate statement, “We are now working diligently to further validate the results of these enhancements and will be back on the market only when we are satisfied that the manufacturing enhancements we have made will give us the desired results.”

The company plans to launch a more tightly rolled version of the MemoryLens as soon as September. In some cases, the lens has been inserted through an incision of less than 3 mm.

“We are looking for a high degree of confidence before we come back to market,” Mr. Bailey said. “Our goal is to return to market with a lens that will go in an even smaller incision and that meets the highest quality standards demanded by CIBA Vision.”

For Your Information:

CIBA Vision can be reached at 11460 Johns Creek Parkway, Duluth, Ga. 30097; (678) 415-3646; fax (678) 415-3592.