AcuFocus has received an approvable letter from the FDA regarding the IC-8 small aperture IOL, according to a press release from the company.
The FDA the company’s premarket approval application be approved following successful inspections at AcuFocus’ manufacturing sites, the release.
“We are thrilled to receive the approvable letter from the FDA ahead of our MDUFA date and we look forward to working with the FDA to successfully complete these customary pre-approval inspections,” Al Waterhouse, president and CEO for AcuFocus, said in the release.
The IC-8 IOL will be