FDAFebruary 13, 2015device
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 cataractous lens has been rem...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Aaren Scientific is recalling intraocular lenses because the instructions for use (IFU) are not fully compliant with US requirements.
What to do
FDA enforcement status: Terminated
Brands named
aaren scientificaaren
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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- FDABoston Scientific Cardiac Resynchronization Therapy (CRT)labeled as: 1. VALITUDE CRT-P EL, Model Number U125; 2. VALITUDE CRT-P EL MRI, Model Number U128; 3. VISIONIST CRT-P EL, Model Number U225; 4. VISIONIST CRT-P EL, Model Number U226; 5. VISIONIST CRT-P EL MRI, Model Number U228.2026-03-19
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