AcuFocus receives approvable letter from FDA for IC-8 IOL
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 said the company’s premarket approval application should be approved following successful inspections at AcuFocus’ manufacturing sites, according to the release.
“We are thrilled to receive the approvable letter from the FDA ahead of our [medical device user fee amendment] 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 available for purchase following the successful completion of inspection of the manufacturing sites, which AcuFocus anticipates happening in the second quarter of 2022.