C-flex Hydrophilic Acrylic Injectable IOL 570C (REF 570C/+23.0)Recalls & reported problems
Rayner Intraocular Lenses Limited · Class 3 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05029867802799), received between Feb 1, 2019 and Sep 17, 2019 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Material Opacification” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Material Opacification1
Patient problems
- Visual Impairment2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 17, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ON 5TH SEPTEMBER 2019, RAYNER INTRAOCULAR LENSES LIMITED RECEIVED NOTIFICATION FROM A US HEALTHCARE FACILITY OF AN EVENT THAT OCCURRED FOLLOWING IMPLANTATION OF A C-FLEX 570C IOL. THE EVENT DESCRIPTION PROVIDED STATES THAT THE PATIENT'S PREDICTED REFRACTIVE OUTCOME WAS -0.32 AND POST-OPERATIVELY THE PATIENT REFRACTIVE OUTCOME IS -5.50.
Patient problems: Visual Impairment
MAUDE report 9075929 ↗MalfunctionFeb 1, 2019Material Opacification; Material Opacification
ON (B)(6) 2019, RAYNER INTRAOCULAR LENSES LIMITED RECEIVED NOTIFICATION FROM A US HEALTHCARE FACILITY OF AN EVENT THAT OCCURRED FOLLOWING IMPLANTATION OF A C-FLEX 570C IOL. THE EVENT DESCRIPTION PROVIDED STATES "ON (B)(6) 2012, I PERFORMED AN UNCOMPLICATED PHACO CATARACT EXTRACTION AND IMPLANTED A RAYNER 570C +23.0. ABOUT SIX MONTHS AGO SHE DEVELOPED AN UNUSUAL OPACIFICATION OF THE CENTRAL ANTERIOR PORTION OF THE IOL OD. THE IOL OS IS CLEAR. IN (B)(6) 2016, SHE UNDERWENT DSEK OD BY ANOTHER OPHTHALMOLOGIST FOR DECOMPENSATED CORNEAL ENDOTHELIAL DYSTROPHY. IN (B)(6) 2016, I PERFORMED A YAG CAPSULOTOMY OD BECAUSE OF POSTERIOR CAPSULE OPACIFICATION. THERE WAS NO EVIDENCE OF A PROBLEM WITH THE IOL AT THAT TIME. SHE HAD HAD SEVERAL INTRAVITREAL INJECTIONS OD BY A RETINAL SPECIALIST FOR DIABETIC RETINOPATHY...THE IOL OPACIFICATION OF THE IOL OD IS ANTERIOR CENTRAL...THE OPACITIES ARE WHITE, COALESCED, GLOBS WHICH APPEAR TO BE JUST UNDER OR ON THE ANTERIOR SURFACE OF THE IOL".
Patient problems: Visual Impairment
MAUDE report 8296919 ↗
Other Intraocular Lens devices
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- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens144 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens139 reports
- TECNIS SIMPLICITY DIB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens1 recall81 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens129 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens127 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens126 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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