Novartis' ($NVS) Alcon expanded the recall of its intraocular lenses in Japan, pushing the number of affected units to 89,042, due to a continued increase in reports of postoperative inflammation among patients who received the AcrySof IQ Toric lens. The recall does not affect IOLs sold outside of Japan, nor any Alcon monofocal and low-cylinder toric IOLs sold in Japan.
The recall was deemed Class 1 by the FDA in its recall database. Class 1 recalls are reserved for situations in which the agency believes "there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death."
The FDA says that Alcon sent a "FDA Notification-Update to Recall" letter on Oct. 1 to consignees in Japan who have received the affected lenses in order to initiate recovery of the device. Under the expanded recall, 43,651 units are affected. The recall notices list the affected model numbers.
At the time, Alcon put out a press release, which states: "The investigation has determined that the increase in cases of post-operative inflammation in Japan is correlated to a combination of the unique surface properties of the Japan IOLs and common processing steps that are used only for AcrySof ReSTOR, ReSTOR Toric, and high-cylinder Toric IOLs (SNA6T6-SNA6T9). Alcon has already identified and is implementing process improvements to prevent recurrence of this issue."
The company said it is "communicating with relevant regulatory authorities globally, including Japan regulatory authorities (MHLW and PMDA) as well as the U.S. Food and Drug Administration (FDA) regarding this expanded market action in Japan and our proposed manufacturing process improvements."
In August, Alcon recalled 45,391 lenses in Japan due to reports of reports of postoperative inflammation and/or toxic anterior segment syndrome following cataract surgery. That recall (also Class 1) applied to its ReSTOR intraocular lens and ReSTOR Toric intraocular lens.
In both cases, the FDA blamed the issue on faulty process design, but did not specify a root cause.
"The manufacturing process for Alcon IOLs manufactured for Japan differs from that used to manufacture IOLs for the rest of the world. Specifically, all IOLs manufactured for Japan undergo a different curing process compared to IOLs manufactured for other markets. As a result, the IOLs manufactured for Japan have different surface properties," Alcon's release says.
Intraocular lenses are implanted in the eye, and replace the light focusing function of the eye's original lens, eliminating the need for contact lenses or glasses. Alcon says implantation of the AcrySof IQ Toric IOLs enables correction of astigmatism.
The recalls come amid a slew of new IOL approvals at Novartis' eye care unit. In June, Alcon received CE mark approval to sell its AcrySof IQ PanOptix trifocal intraocular lens in Europe. The implantable lens corrects near, intermediate and distance vision in cataract patients. And in April it received FDA approval for its implantable AcrySof IQ ReSTOR +2.5 Diopter intraocular lens, enabling vision correction at all distances in eye care patients with or without presbyopia who undergo cataract surgery.
Alcon is still awaiting word from the FDA about the AcrySof IQ ReSTOR Multifocal Toric Intraocular Lens, even though the device received an FDA advisory committee's strong recommendation last November. It is for patients suffering from both astigmatism and presbyopia. If approved, it would be first multifocal IOL in the U.S. that corrects corneal astigmatism and provides near, intermediate and distance vision.
Meanwhile, Novartis plans to next year test in people with presbyopia (age-related farsightedness) a "smart" contact lens for vision correction that's being developed with Google Life Sciences. Also in the works is another jointly developed smart contact lens for diabetes, allowing patients to measure glucose from their tears using a miniaturized sensor and a wireless chip.
- read Alcon's press release put out in October
- read the recall notice | here's the August notice
Editor's Note: This article has been updated with additional information from an Alcon release issued when the recall occurred in October.