|Alcon marketed its LenSx Laser without gaining proper regulatory clearance for updated software.--Courtesy of Alcon|
Alcon marketed its LenSx laser to treat cataracts without gaining proper regulatory clearance for updated software and other improvements to the product, the FDA alleges in a warning letter citing the company. Regulators also knocked Alcon for not providing sufficient proof that it developed ways to address and correct manufacturing problems when they occur.
The Dec. 3, 2012 warning letter stems from an FDA inspection of Alcon's Aliso Viejo, CA, manufacturing facility from June 7-Aug. 2, 2012.
An Alcon spokesperson told FierceMedicalDevices via email that the warning letter "does not question the safety or effectiveness of the LenSx laser." He added that the product, the first femtosecond laser FDA cleared for refractive cataract surgery, remains on the market.
The spokesperson said Alcon has since responded to the FDA in writing, providing additional data and information within the proper 15-day timeframe in an attempt to resolve all issues. And as of Feb. 11, 2013, "Alcon received a response from the FDA acknowledging that the corrective actions of the company appear to address the items identified in the warning letter," the spokesperson noted. Regulators will conduct a future inspection in person to verify everything has been addressed, according to the company.
FDA regulators were, in part, concerned that Alcon didn't seek fresh clearance for updated software versions for LenSx, such as better graphical user interface, and technical service routines performed outside of the surgical procedure.
- read the warning letter
PolyActiva pulls in $9.5M for intraocular implant work
Glaukos snags $30M venture round for tiny eye stent
Bausch + Lomb grabs German ophthalmology laser company