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AMO recalls Endosol after reports of toxic anterior segment syndrome
About 30 practices have reported cases of TASS possibly related to the product, according to the company.
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Reports of toxic anterior segment syndrome in patients after cataract surgery led Advanced Medical Optics to voluntarily recall its balanced salt solution product, Endosol, according to the company.
The Food and Drug Administration is currently conducting an investigation at a manufacturing facility of Cytosol Laboratories, the maker of Endosol under a contract with AMO.
“AMO has received reports that some physicians using the AMO Endosol products have observed toxic anterior segment syndrome (TASS) in their patients following surgery,” said Sandra Selvaggi, AMO’s vice president of worldwide quality assurance, in an announcement of the recall issued to AMO customers by AMO on November 18.
TASS can occur when a contaminant enters the anterior segment during surgery, causing an inflammatory reaction.
The recall affects all lots of 500 mL glass bottles (product code END500); 500 mL plastic bottles (product code 0850) and 18 mL plastic squeeze bottles (product code 0997) of the product, according to the announcement from AMO, and is limited to the U.S. market.
“All lot numbers of Endosol are being recalled because endotoxin levels above the [United States Pharmacopeia] maximum levels have been noted in some bottles tested within the AMO Endosol lots,” the announcement said. “Endotoxin levels above the maximum level may be potential causes of an inflammatory response and/or TASS in patients following surgery.”
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What is TASS? |
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Toxic anterior segment syndrome is a noninfectious inflammation of the anterior segment that can occur within the first 24 hours or so after cataract surgery. According to Nick Mamalis, MD, the speed of onset of the inflammation is one of the characteristics that differentiate TASS from infectious endophthalmitis. “Usually patients will have symptoms certainly within 24 hours of the surgery, and often patients will even have symptoms on the day of surgery,” he said. Dr. Mamalis has been analyzing outbreaks of TASS for the past 10 years at the John A. Moran Eye Center with the help of a grant from the American Society of Cataract and Refractive Surgery. He said that in his experience, endotoxin is one of numerous causes of TASS. Depending on the severity of the case, he said, symptoms can range from mild corneal edema to permanent corneal edema in severe cases coupled with iris atrophy and difficult-to-control glaucoma. He also said the severity depends on what type of toxin caused the outbreak. “It depends on the concentration of what the material was that caused this as well as how much of it got into the eye,” he said. |
The company requested that all AMO Endosol lots be removed from inventories and that a fax form with all pertinent information regarding the lots be returned to AMO within three days of receipt of the announcement.
While investigations continue, AMO recommended that their customers use Hospira or Baxter as alternative vendors for 500 mL glass bottles of balanced salt solution.
In an interview with Ocular Surgery News, Ron Clarke, Cytosol’s vice president of global sales and marketing, said that the company looks forward to providing more information as it becomes available.
A statement by Cytosol’s president, Court Lewis, posted on the company’s Web site on November 16, states that Cytosol has confirmed the safety of its product.
“Cytosol Ophthalmics brand balanced salt solution products have undergone extensive testing and retesting in the past week and no adverse results have been found,” the statement said. “Cytosol Ophthalmics continues to ship all of our irrigation products to the large base of customers we support every day in the United States as well as to more than 35 other countries.”
Initial reports
The problem was brought to light in mid-October primarily through reports to AMO’s complaint handling system. According to AMO spokesperson Steve Chesterman, a standard complaint investigation, including testing the product for pH, osmolarity, sterility and endotoxin levels, was initiated upon hearing these reports.
“The product involved in the complaint investigations was returned from the AMO accounts for testing. All product was found to be within product specifications, including endotoxin levels,” Ms. Selvaggi told Ocular Surgery News during a telephone interview.
According to Ms. Selvaggi, AMO’s decision to issue an initial safety alert on November 10 was made when AMO became aware of positive endotoxin levels in a lot of AMO Endosol product forwarded to the Centers for Disease Control for testing.
“When we have conflicting data in an investigation, our biggest concern is our patients’ safety,” Ms. Selvaggi said. “The safety alert was a precautionary step to remove product from use to prevent any additional patient cases of inflammation while we continued the investigation.”
When further endotoxin testing conducted by an outside laboratory for AMO revealed similar results, the company issued the product recall, she said.
Ms. Selvaggi said that approximately 30 AMO accounts have reported TASS events associated with the AMO Endosol.
Cytosol has been manufacturing and distributing balanced salt solution for more than 19 years, according to the company. It has been supplying AMO with Endosol since 2000, according to Mr. Clarke. Before that, the product was manufactured by Allergan, he said.
AMO has been distributing Endosol for more than 10 years, according to Mr. Chesterman.
For Your Information:
- Sandy Selvaggi, AMO’s vice president of worldwide quality assurance, can be reached at Advanced Medical Optics, 1700 E. St. Andrew Place, P.O. Box 25162, Santa Ana, CA 92799-5162; 714-247-8656.
- Steve Chesterman can be reached at Advanced Medical Optics Inc., 1700 E. St. Andrew Place, P.O. Box 25162, Santa Ana, CA 92799-5162; 714-247-8711; e-mail: steve.chesterman@amo-inc.com.
- Ron Clarke, Cytosol’s vice president of global sales and marketing, can be reached at Cytosol Ophthalmics-Lenoir Inc., P.O. Box 1408, 1325 William White Place NE, Lenoir, NC 28645; 828-758-2343; e-mail: rclarke@cytosol.com.
- Jared Schultz is an OSN Staff Writer who covers all aspects of ophthalmology. He focuses geographically on Europe and the Asia-Pacific region.