Data / Medical devices / United Kingdom / Rayner Intraocular Lenses Limited
Rayner Intraocular Lenses Limited: FDA-registered device maker in Worthing West Sussex, United Kingdom, 1 PMA approval
Rayner Intraocular Lenses Limited is registered with the FDA (registration 3012304651) in Worthing West Sussex, United Kingdom. It lists 3 device types. The FDA files 1 PMA approval under its listings, the newest dated May 3, 2007. 3 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3012304651
- Address
- The Ridley Innovation Centre 10 Dominion Way, Worthing West Sussex, United Kingdom, BN14 8AQ
- Owner or operator
- Rayner Intraocular Lenses Limited (8010143)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- December 12, 2007
- Registered through
- 2026
- Brand names listed
- Model RAO100C, Model RAO200E, Model RAO600C, RayOne EMV Toric
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Intraocular Lens | HQL | 3 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Lens, Intraocular, Toric Optics | MJP | 3 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Lens, Multifocal Intraocular | MFK | 3 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| May 3, 2007 | P060011 | C-FLEX MODEL 570C INTRAOCULAR LENS (IOL) | HQL | 42 | September 24, 2026 | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| May 13, 2022 | 90301 | Class II | Ongoing | 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) Inn | The outer package is mislabeled and the package contains a different IOL strength. | accessdata.fda.gov |
| March 17, 2020 | 85270 | Class II | Ongoing | 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 t | 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. | accessdata.fda.gov |
| August 9, 2018 | 80943 | Class II | Terminated | 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. | accessdata.fda.gov |
Compare with other makers
- All makers of Lens, Intraocular, Toric Optics
- All makers of Lens, Multifocal Intraocular
- All makers of Intraocular Lens
Updated September 24, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.