C-flex 570C +19.0D Intraocular Lens Product Usage: C-flex IOLs are designed to be surgically implanted into the capsular bag of the human eye as a replacement for the crystalline lens following phacoemulsification
Check against the official notice below — it lists the full affected range.
Rayner Intraocular Lenses Limited has recalled 49 C-flex 570C +19.0D intraocular lenses distributed in Missouri. These lenses are surgically implanted into the eye to replace the natural lens. The recall was initiated after the manufacturer became aware of reports of post-operative refractive errors (focusing problems) following implantation of lenses from Batch 017100825.
The affected lenses have serial numbers 01710082501 through 01710082549. The recall notice does not specify a remedy or recommended action for consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
Firm become aware of reports of post-operative refractive errors following implantation of lenses.
Reason for recall: Firm become aware of reports of post-operative refractive errors following implantation of lenses. Distribution: US in the states of MO Quantity: 49 Lot/code info: Batch 017100825 Lens #'s: 01710082501, 01710082502, 01710082503, 01710082504, 01710082505, 01710082506, 01710082507, 01710082508, 01710082509, 01710082510, 01710082511, 01710082512, 01710082513, 01710082514, 01710082515, 01710082516, 01710082517, 01710082518, 01710082519, 01710082520, 01710082521, 01710082522, 01710082523, 01710082524, 01710082525, 01710082526, 01710082527, 01710082528, 01710082529, 01710082530, 01710082531, 01710082532, 01710082533, 01710082534, 01710082535, 01710082536, 01710082537, 01710082538, 01710082539, 01710082540, 01710082541, 01710082542, 01710082543, 01710082544, 01710082545, 01710082546, 01710082547, 01710082548, and 01710082549.
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.