Rayner Intraocular Lenses Limited
FDA adverse event reports naming Rayner Intraocular Lenses Limited as the device manufacturer, with recall history from the live FDA recall database. Reporter-supplied name as filed: RAYNER INTRAOCULAR LENSES LIMITED.
- Total reports
- 1,623
- Deaths
- 0
- Injuries
- 86
- Malfunctions
- 1,475
Reports per year
Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Top device categories
Recent recalls
- Open, ClassifiedLabeling mix-ups
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.
- TerminatedError in labeling
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.
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