AcuFocus receives approvable letter from FDA for IC-8 IOL
Click Here to Manage Email Alerts
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.
Perspective
Back to Top
As surgeons, we are always happy to have more IOL options for our patients. With the addition of the AcuFocus IC-8 with the small-aperture design, we will have a third option in the class of extended depth of focus IOLs.
Cataract surgeons have been using the Alcon Vivity beam-shaping EDOF IOL and the diffractive ring Johnson & Johnson Vision Tecnis Symfony EDOF IOL with success in patients who desire less reliance on spectacles for the near and intermediate vision ranges. The AcuFocus IC-8 elongates the depth of focus using a smaller aperture, much like a photographer using a higher F-stop to decrease the aperture and extend the depth of field. The image quality with the IC-8 should be excellent without dysphotopsias, although there will be less light entering the eye, which may hinder night vision to a degree. Finally, there may also be other clinically useful situations for the IC-8, such as patients with irregular corneas after RK surgery.
I congratulate AcuFocus for working hard to bring this IOL to U.S. surgeons.
Read more about
Click Here to Manage Email Alerts