Tool For Evaluating LASIK Outcomes Gets FDA Qualification
The US FDA has qualified a tool used to assess patient outcomes of LASIK surgery as scientifically valid. The qualification aims to support the agency’s pre- and post-market regulatory decisions and aid manufacturers in the development of devices for the procedure.
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The comment period for a draft guidance document on labeling for LASIK surgery equipment has been extended for another month. Ninety people have already filed comments, representing a wide range of views about the procedure.
The document would ask manufacturers to include additional plain-language labeling to ensure people considering LASIK have additional information about potential side effects and contraindications.
A group of patient advocates including one former US FDA official met with agency staff on Sept. 13 to raise awareness about adverse events tied to LASIK surgery. The group said the vision-correcting procedure is too risky to be offered as elective surgery.