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Alcon deactivates LADAR6000 algorithms for myopia
The algorithms were linked to central islands and decreases in visual acuity that may not be correctable with glasses or lenses.
Alcon has officially completed the deactivation of two algorithms used for CustomCornea treatment of myopia with or without astigmatism, the U.S. Food and Drug Administration announced.
The algorithms, M3 and A7, were recalled in February in response to reports of corneal abnormalities or “central islands” that may not be correctable with laser therapy. Use of the algorithms has also been linked with a decrease in visual acuity that may not be correctable with glasses or contact lenses, according to the FDA.
Health care professionals in possession of the LADAR6000 were notified of the problem in a recall notice from Alcon dated Feb. 21. The recall notice directed physicians to discontinue performing CustomCornea procedures using the LADAR6000 system for treatment of myopia. On May 11, Alcon updated physicians in a letter stating that Alcon will deactivate the device’s ability to perform CustomCornea myopia and CustomCornea myopia with astigmatism procedures.
The laser had been used on patients older than 21 years who had a stable refraction for at least a year, as documented by a change of sphere and cylinder of 0.5 D or less, the FDA said.
The recalled algorithms have now been deactivated in all LADAR6000 units in the United States. A total of 102 systems were distributed worldwide between Aug. 17, 2005, and Feb. 21, 2007. Eighteen are held in Alcon’s possession, and two are being held by a freight handler. Approximately 89 of these systems were distributed in the United States.
No re-launch date announced
In its most recent earnings report, Alcon said it has “submitted a pre-market authorization supplement to the FDA with proposed corrective actions to the machine.”
Company officials have been working with members of the research and development facility in Orlando, Fla., to determine the root cause of the problem, but officials declined to say when they expect to re-launch the device.
“There has been no new movement with the FDA and no agreement to get the algorithms back online,” Kathleen Golden, an Alcon senior specialist in corporate communications, told Ocular Surgery News.
According to David Avila, marketing manager of the refractive division, Alcon “has not yet determined which one or which combination of possible factors is causing the central islands. Because we weren’t sure, we decided to deactivate the algorithms until we could fully understand what is causing these cases.”
Sarah Ross, product manager of the LADAR6000, maintained that surgeons can still perform procedures with the device, just not for myopia or myopia with astigmatism.
“We’ve been in constant contact with the FDA since February when the first reports of central islands occurred. As we move forward, we are taking every opportunity to evaluate our existing portfolio and determine the best course of action,” she said.
Recall limited to algorithms
The recall, categorized by the FDA as a class 1 recall, is limited to the algorithms and not the device itself.
Kristine Mejia, an FDA spokesperson, said class 1 recalls “are for dangerous or defective products that predictably could cause serious health problems or death. In analyzing this situation, we found it to be serious enough to warrant a class 1 designation.”
Ms. Mejia declined to say how many patients were affected. FDA personnel noted that currently there are no FDA-approved treatment algorithms for central islands.
Medical device attorney and OSN Regulatory/Legislative Section Member Wayne H. Matelski, JD, of the Washington, D.C.,-based law firm Arent Fox, said Alcon “acted prudently, quickly and appropriately” in deactivating the algorithms. “Alcon did so since they thought it was serious enough because of the imminent danger to people’s health,” he said.
OSN attempted to contact those ophthalmologists who are members of the FDA medical device panel, but all declined to comment.
For more information:
- Wayne H. Matelski, JD, can be reached at Arent Fox LLP, 1050 Connecticut Ave., N.W., Washington, DC 20036; 202-857-6462; fax: 202-857-6395; e-mail: matelski.wayne@arentfox.com.
- Kristine Mejia can be reached at the U.S. Food and Drug Administration, 5600 Fishers Lane, Suite 15A-07, Rockville, MD 20857; 301-827-6697; fax: 301-827-1681; e-mail: kristine.mejia@fda.hhs.gov.
- David Avila can be reached at Alcon Laboratories, 6201 S. Freeway, Fort Worth, TX 76134; 817-293-0450; fax: 817-568-7027; e-mail: david.avila@alconlabs.com.
- Kathleen Golden can be reached at Alcon, 6201 S. Freeway, Fort Worth, TX 76134; 817-293-0450; fax: 817-302-4300; e-mail: kathleen.golden@alconlabs.com.
- Sarah Ross can be reached at Alcon, 6201 S. Freeway, Fort Worth, TX 76134; 817-293-0450; fax: 817-568-7027; e-mail: sarah.ross@alconlabs.com.
- John Misiano is an OSN Staff Writer who covers all aspects of ophthalmology.