Aaren Scientific Recalls Intraocular Lenses Due to Non-Compliant Instructions
Aaren Scientific is recalling 28 intraocular lenses because the instructions for use do not fully comply with US requirements.
- Product
- Intraocular Lens (IOL), Part No. EC-3 PAL, Diopter: 17.5, 18.0, 18.5, 19.0, 19.5, 21.5, 23.5, 9.0, 22.5, 23.0, 21.0, 24.0. The device is indicated for primary implantation in the capsular bag of the eye for the visual correction of aphakia in adult patients in whom a cataract
- Category
- Medical Device
- Distribution
- 4 states