Rayner Intraocular Lenses Limited
Worthing West Sussex, GB
Rayner Intraocular Lenses Limited appears in FDA device records in Worthing West Sussex, GB. FDA records list 4 510(k) clearances between and , 42 PMA records and one registered establishment. As of , FDA records show 3 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 4 510(k) clearances for Rayner Intraocular Lenses Limited between 2009 and 2014. The busiest year on record is 2014, with 3. The most recent is 2014, with 3.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2009 | 1 |
| 2014 | 3 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K143307 | RaySert PLUS Injector, Single Use Soft Tipped Disposable Injector | MSS | Substantially Equivalent | |
| K141091 | RAYSERT PLUS INJECTOR | MSS | Substantially Equivalent | |
| K132002 | SINGLE USE SOFT TIPPED DISPOSABLE INJECTOR, RAYSERT SINGLE USE SOFT TIPPED SMALL INCISION DISPOSABLE INJECTOR | MSS | Substantially Equivalent | |
| K091507 | RAYNER SMALL INCISION SINGLE USE SOFT TIPPED INJECTOR, MODEL R-INJ-04/18 | MSS | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3012304651 | 3012304651 | Rayner Intraocular Lenses Limited | The Ridley Innovation Centre, Worthing West Sussex BN14 8AQ GB | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| 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. | The outer package is mislabeled and the package contains a different IOL strength. | Class II | Open, Classified | |
| Z-1753-2020 | 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 intraocular lenses that allow the use of these injectors in their approved labelling. | RaySert PLUS RSP01 LOT K030 labeled with an expiry of 2024-01 contained an inner tray that was labeled with an expiry of 2015. In addition to having an expiry of 2015 the LOT number on the inner tray is identified as V001. | Class II | Open, Classified | |
| Z-3282-2018 | 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 | Firm become aware of reports of post-operative refractive errors following implantation of lenses. | Class II | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain