FDAAugust 9, 2018device
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
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Firm become aware of reports of post-operative refractive errors following implantation of lenses.
What to do
FDA enforcement status: Terminated
Brands named
rayner intraocular lensesraynerrayner intraocular
UPCs
017100825010171008250201710082503017100825040171008250501710082506017100825070171008250801710082509017100825100171008251101710082512
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDARayOne Preloaded Hydrophilic Acrylic IOL Injection Systems containing one MICS injection system with Intraocular Lens: (1) Outer carton labeled as Rayner RayOne EMV US, REF RAO200E, SE: +19.00D, Sph: +19.00D; and (2) Inner primary device packaging labeled as Rayner RayOne EMV US, REF RAO200E, SE:...2022-05-13
- FDARaySert PLUS RSP01. LOT K030. Expiry of 2024-01 - Product Usage: The single use injectors (Model STWOl and Model RSPOl) are intended to be used to compress and insert into the capsular bag only those intraocular lenses that allow the use of these injectors in their approved labelling.2020-03-17
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