Reprinted with permission from fdaweb.com
CDRH to Review 18 ‘Violative’ LASIK Ads
Responding to a complaint by Florida-based LASIK activist Dean Andrew Kantis, CDRH’s Office of Compliance said 9/11 it would give “appropriate review” to 18 Web site advertisements by LASIK surgery firms that Kantis had gathered and sent to office director Timothy A. Ulatowski. Founder of the Life After LASIK Web network, Kantis said in his transmittal that all of the ads violated Ulatowski’s 5/22 letter to LASIK professionals that set out requirements for LASIK promotions. FDA Webview reviewed four of the ads and determined that none of them complied with the letter, which among other things said such ads should disclose risks associated with the controversial procedure.
Kantis and other activists have been conducting a sustained pressure campaign on FDA’s new leadership to take regulatory action against ambulatory surgical facilities that they say perform LASIK vision-enhancement procedures without required patient informed consent and fair disclosure of permanent injuries that reportedly run as high as 20% of all surgeries. Since their complaints were aired at an open advisory panel meeting last year, CDRH has declined to respond to requests that it initiate inspections of these facilities to ascertain their compliance with MDR reporting requirements.
Last week, former CDRH chief of LASIK reviews Morris Waxler told FDA Webview the agency had “screwed up” in the adverse events it allowed LASIK lasers to cause when it approved this indication in 1998.
In a comment on Kantis’ complaint about the 18 ads, FDA’s Press Office told FDA Webview: “We acknowledge receipt of these ads and will give them appropriate review. Without enough time to review, it is not helpful to speculate on potential regulatory action, nor can we comment on an investigation should we initiate one.”
Meanwhile, FDA’s closure of a public docket it opened last year on LASIK quality-of-life issues occurs 9/14.