Rayner Intraocular Lenses , Ltd.

• MSS — Ophthalmic4 devices

• Z-1338-2022 — 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: +21.00D, Sph: +21.00D.Class II·Ongoing·2022-05-13

Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.

• K143307 — RaySert PLUS Injector, Single Use Soft Tipped Disposable InjectorCode MSS·2014-12-18
• K141091 — RAYSERT PLUS INJECTORCode MSS·2014-05-28
• K132002 — SINGLE USE SOFT TIPPED DISPOSABLE INJECTOR, RAYSERT SINGLE USE SOFT TIPPED SMALL INCISION DISPOSABLE INJECTORCode MSS·2014-03-27
• K091507 — RAYNER SMALL INCISION SINGLE USE SOFT TIPPED INJECTOR, MODEL R-INJ-04/18Code MSS·2009-12-04