Company ยท GB
Rayner Intraocular Lenses , Ltd.
FDA 510(k) clearances and medical device recalls filed under this name, 2009 to 2014. Name variants (Inc, Corp, punctuation) are merged.
4510(k) clearances (0 in 12 months)
3recalls (0 in 12 months)
1recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 18, 2014 | K143307 | RaySert PLUS Injector, Single Use Soft Tipped Disposable Injector Rayner Intraocular Lenses , Ltd., GB | MSS |
| May 28, 2014 | K141091 | RAYSERT PLUS INJECTOR Rayner Intraocular Lenses , Ltd., GB | MSS |
| Mar 27, 2014 | K132002 | SINGLE USE SOFT TIPPED DISPOSABLE INJECTOR, RAYSERT SINGLE USE SOFT TIPPED SMALL INCISION DISPOSABLE INJECTOR Rayner Intraocular Lenses , Ltd., GB | MSS |
| Dec 4, 2009 | K091507 | RAYNER SMALL INCISION SINGLE USE SOFT TIPPED INJECTOR, MODEL R-INJ-04/18 Rayner Intraocular Lenses , Ltd., GB | MSS |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 13, 2022 | Rayner Intraocular Lenses Ltd 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: Open, Classified |
HQL | None listed |
| Mar 17, 2020 | Rayner Intraocular Lenses Limited RaySert 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 Open, Classified |
MSS | K141091 |
| Aug 9, 2018 | Rayner Intraocular Lenses Limited 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 phaco Terminated |
HQL | None listed |