FDAMay 13, 2022device
RayOne 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:...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
The outer package is mislabeled and the package contains a different IOL strength.
What to do
FDA enforcement status: Ongoing
Brands named
rayner intraocular lensesraynerrayner intraocular
UPCs
0502986700668505029867006722
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- 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
- FDAC-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 phacoemulsification2018-08-09
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