Santa Ana, CA—Abbott Medical Optics (AMO) said it has decided to halt future production of its newest ophthalmic viscosurgical device (OVD), 3% sodium hyaluronate (Healon D), citing concerns about the company's ability to ensure a continuous supply to the market.

"The raw materials and processes used in [3% sodium hyaluronate] production are unique to [the product] and are not used for our other [OVD] products," said Steve Chesterman, AMO manager, global corporate communications, in an e-mail response to questions posed by Ophthalmology Times. "We are taking proactive steps to ensure the ability to supply [this OVD], and our goal is to make sure we can continually produce product to meet the needs of our customers and avoid delays and/or back orders."

Letters were mailed to customers in mid-April informing them that the manufacturer would be suspending production, according to Chesterman. Although he emphasized that the OVD was not being withdrawn from the market, he added that the decision to suspend its production was related to the outcome of an investigation into problems with the product last fall.

AMO voluntarily recalled a single lot of the product Oct. 30 after physicians noticed inflammation at some patients' 1-day postoperative visit. The lot was recalled because endotoxin levels exceeded product guidelines in some syringes. Elevated endotoxin levels could cause an inflammatory response or toxic anterior segment syndrome in patients following surgery. The FDA followed with a Class I recall because the lot posed a "significant potential for harm to human health," according to FDA spokeswoman Siobhan DeLancey.

FDA pre-market approval previously was granted Oct. 8 for the OVD for use as a surgical aid in cataract extraction, IOL implantation, corneal transplant, and glaucoma filtration surgery. The product provided "exceptional" clarity in the surgical field, and its low molecular weight ensured that the OVD remained in the eye after phacoemulsification to protect endothelial cells, according to AMO.

Customers may continue to use existing supplies of 3% sodium hyaluronate "with confidence," Chesterman said. Customers alternatively are being directed to try 2.3% sodium hyaluronate (Healon5, AMO), a dual-property viscoadaptive that behaves like a cohesive and a dispersive agent.

According to data compiled by Market Scope, AMO holds about 16% of the total U.S. OVD market, he said. David Harmon, president of Market Scope, declined to comment.

"We will continue to pursue offering a dispersive OVD for U.S.-based customers," Chesterman said. "We will also continue to provide all other [OVD] products on a global basis, including 1% sodium hyaluronate [Healon], 1.4% sodium hyaluronate [Healon GV], and 2.3% sodium hyaluronate. Our dispersive viscoelastic [Vitrax II] is also available in Canada, Europe, and other selected global markets."