RayOne AsphericRecalls & reported problems across all models
Rayner Intraocular Lenses Limited · 20 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 44
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 0
We found 20 models of RayOne Aspheric by Rayner Intraocular Lenses Limited in the FDA's device registry (GUDID). Together they are named in 44 adverse event reports in the FDA's MAUDE database, received between Aug 15, 2019 and Jun 23, 2026 — classified as 44 malfunctions.
The most frequently reported specific device problem is “Material Split, Cut or Torn” (8 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported RayOne Aspheric problems
Device problems
- Adverse Event Without Identified Device or Use Problem11
- Material Split, Cut or Torn8
- Insufficient Device Problem Information4
- Scratched Material4
- Crack3
- Optical Decentration3
- Optical Problem3
- Appropriate Device Problem Term/Code Not Available2
Patient problems
- No Clinical Signs, Symptoms or Conditions21
- Visual Impairment10
- Visual Disturbances4
- Capsular Bag Tear3
- Intraocular Pressure Increased2
- No Code Available2
- Blurred Vision1
- Corneal Edema1
RayOne Aspheric models
20 models, most reported first. Each model has its own page with its reports, recalls and device details.
- RayOne Aspheric RAO600CIntraocular Lens7 reports
- RayOne Aspheric RAO600CIntraocular Lens3 reports
- RayOne Aspheric RAO600CIntraocular Lens3 reports
- RayOne Aspheric RAO600CIntraocular Lens3 reports
- RayOne Aspheric RAO600CIntraocular Lens3 reports
- RayOne Aspheric RAO600CIntraocular Lens3 reports
- RayOne Aspheric RAO600CIntraocular Lens2 reports
- RayOne Aspheric RAO600CIntraocular Lens2 reports
- RayOne Aspheric RAO600CIntraocular Lens2 reports
- RayOne Aspheric RAO600CIntraocular Lens2 reports
- RayOne Aspheric RAO600CIntraocular Lens2 reports
- RayOne Aspheric RAO600CIntraocular Lens2 reports
- RayOne Aspheric RAO600CIntraocular Lens2 reports
- RayOne Aspheric RAO600CIntraocular Lens2 reports
- RayOne Aspheric RAO600CIntraocular Lens1 report
- RayOne Aspheric RAO600CIntraocular Lens1 report
- RayOne Aspheric RAO600CIntraocular Lens1 report
- RayOne Aspheric RAO600CIntraocular Lens1 report
- RayOne Aspheric RAO600CIntraocular Lens1 report
- RayOne Aspheric RAO600CIntraocular Lens1 report
Recent RayOne Aspheric adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionJun 23, 2026Mechanical Problem
ON (B)(6) 2026, RAYNER RECEIVED NOTIFICATION FROM A US HEALTHCARE FACILITY OF AN EVENT THAT OCCURRED FOLLOWING IMPLANTATION OF A RAYONE ASPHERIC RAO600C. THE EVENT DESCRIPTION PROVIDED STATES LENS EXPLANTED DUE TO "MECHANICAL COMPLICATIONS".
Patient problems: Insufficient Information
MAUDE report 25592681 ↗MalfunctionJun 22, 2026Crack
ON 10TH JUNE 2026, RAYNER RECEIVED NOTIFICATION FROM A US HEALTHCARE FACILITY OF AN EVENT THAT OCCURRED DURING USE OF A RAYONE ASPHERIC RAO600C. THE EVENT DESCRIPTION PROVIDED STATES THAT IMMEDIATELY FOLLOWING IMPLANTATION INTO THE EYE THE OPTIC WAS OBSERVED TO BE CRACKED NECESSITATING LENS EXPLANTATION AND EXCHANGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25577121 ↗MalfunctionJun 3, 2026Adverse Event Without Identified Device or Use Problem
ON 13TH MAY 2026, RAYNER RECEIVED NOTIFICATION FROM A US HEALTHCARE FACILITY OF AN EVENT THAT OCCURRED DURING USE OF A RAYONE ASPHERIC RAO600C. THE EVENT DESCRIPTION PROVIDED STATES THAT THE CAPSULAR BAG TORE DURING IOL IMPLANTATION.
Patient problems: Capsular Bag Tear
MAUDE report 25374362 ↗MalfunctionMay 22, 2026Material Split, Cut or Torn
ON 6TH MAY 2026, RAYNER RECEIVED NOTIFICATION FROM A US HEALTHCARE FACILITY OF AN EVENT THAT OCCURRED DURING USE OF A RAYONE ASPHERIC RAO600C. THE EVENT DESCRIPTION PROVIDED STATES THAT IMMEDIATELY FOLLOWING IMPLANTATION INTO THE EYE A CUT IN THE CENTRE OF THE LENS WAS IDENTIFIED NECESSITATING LENS EXPLANTATION AND EXCHANGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25253546 ↗MalfunctionApr 28, 2026Material Split, Cut or Torn
ON 16TH APRIL 2026, RAYNER RECEIVED NOTIFICATION FROM ITS US REPRESENTATIVES OF AN EVENT THAT OCCURRED DURING USE OF A RAYONE ASPHERIC RAO600C. THE EVENT DESCRIPTION PROVIDED STATES THAT THE HAPTIC WAS TORN ON IMPLANTATION INTO THE EYE NECESSITATING LENS EXPLANTATION AND EXCHANGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25016210 ↗MalfunctionApr 28, 2026Material Split, Cut or Torn
ON 16TH APRIL 2026, RAYNER RECEIVED NOTIFICATION FROM A US HEALTHCARE FACILITY OF AN EVENT THAT OCCURRED DURING USE OF A RAYONE ASPHERIC RAO600C. THE EVENT DESCRIPTION PROVIDED STATES THAT ON IMPLANTATION INTO THE EYE THE TRAILING HAPTIC WAS MISSING NECESSITATING LENS EXPLANTATION AND EXCHANGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25016149 ↗MalfunctionApr 28, 2026Material Integrity Problem
ON 17TH APRIL 2026, RAYNER RECEIVED NOTIFICATION FROM A US HEALTHCARE FACILITY OF AN EVENT THAT OCCURRED DURING USE OF A RAYONE ASPHERIC RAO600C. THE EVENT DESCRIPTION PROVIDED STATES THAT DEFECTS WERE NOTED ON THE IOL FOLLOWING IMPLANTATION INTO THE EYE NECESSITATING LENS EXPLANTATION AND EXCHANGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25016012 ↗MalfunctionMar 3, 2026Crack
ON 18TH FEBRUARY 2026. RAYNER RECEIVED NOTIFICATION FROM A US HEALTHCARE FACILITY OF AN EVENT THAT OCCURRED DURING USE OF A RAYONE ASPHERIC RAO600C. THE EVENT DESCRIPTION PROVIDED STATES THAT IMMEDIATELY FOLLOWING IMPLANTATION INTO THE EYE THE OPTIC WAS CRACKED NECESSITATING LENS EXPLANTATION AND EXCHANGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24494671 ↗MalfunctionNov 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ON 19TH NOVEMBER 2025, RAYNER RECEIVED NOTIFICATION FROM A US HEALTHCARE FACILITY OF AN EVENT THAT OCCURRED DURING USE OF A RAYONE ASPHERIC RAO600C. THE EVENT DESCRIPTION PROVIDED STATES THAT POST-OPERATIVELY THE PATIENT EXPERIENCED DYSPHOTOPSIA NECESSITATING ADDITIONAL SURGERY TO EXPLANT THE LENS.
Patient problems: Visual Disturbances
MAUDE report 23670428 ↗MalfunctionNov 24, 2025Optical Problem; Optical Problem
ON 11TH NOVEMBER 2025, RAYNER RECEIVED NOTIFICATION FROM A US HEALTHCARE FACILITY OF AN EVENT THAT OCCURRED FOLLOWING IMPALNTATION OF A RAYONE ASPHERIC RAO600C. THE EVENT DESCRIPTION PROVIDED STATES THAT THE PATIENT IS EXPERIENCING POST-OPERATIVE NEGATIVE DYSPHOTOPSIA AND REQUIRED AN ADDITIONAL SURGERY TO EXPLANT AND EXCHANGE THE LENS.
Patient problems: Visual Disturbances; Visual Impairment
MAUDE report 23629147 ↗MalfunctionNov 3, 2025Positioning Problem; Scratched Material; Positioning Problem; Scratched Material
ON (B)(6) 2025, RAYNER RECEIVED NOTIFICATION FROM A US HEALTHCARE FACILITY OF AN EVENT THAT OCCURRED DURING USE OF A RAYONE ASPHERIC RAO600C. THE EVENT DESCRIPTION PROVIDED STATES THAT ON IMPLANTATION INTO THE EYE SCRATCHES WERE OBSERVED ON THE IOL AND THE TRAILING HAPTIC WAS NOT IN THE EXPECTED POSITION. THE LENS WAS EXPLANTED AND EXCHANGED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23450018 ↗MalfunctionNov 3, 2025Material Split, Cut or Torn; Material Split, Cut or Torn
ON 16TH OCTOBER 2025, RAYNER RECEIVED NOTIFICATION FROM A US HEALTHCARE FACILITY OF AN EVENT THAT OCCURRED DURING USE OF A RAYONE ASPHERIC RAO600C. THE EVENT DESCRIPTION PROVIDED STATES THAT WHEN THE SURGEON WAS IMPLANTING THE LENS THERE WAS SOME RESISTANCE AND WHEN DELIVERED INTO THE EYE ONE HAPTIC WAS BROKEN NECESSITATING LENS EXPLANTATION AND EXCHANGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23448866 ↗MalfunctionSep 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ON 11TH SEPTEMBER 2025, RAYNER RECEIVED NOTIFICATION FROM A US HEALTHCARE FACILITY OF AN EVENT THAT OCCURRED DURING USE OF A RAYONE ASPHERIC RAO600C. THE EVENT DESCRIPTION PROVIDED STATES THAT THE CAPSULE TORE DURING IOL IMPLANTATION.
Patient problems: Capsular Bag Tear
MAUDE report 23071607 ↗MalfunctionSep 8, 2025Optical Problem; Optical Problem
ON 28TH AUGUST 2025, RAYNER RECEIVED NOTIFICATION FROM A US HEALTHCARE FACILITY OF AN EVENT THAT OCCURRED FOLLOWING IMPLANTATION OF A RAYONE ASPHERIC RAO600C. THE EVENT DESCRIPTION PROVIDED STATES THAT POST-OPERATIVELY THE PATIENT PRESENTED WITH A REFRACTIVE SURPRISE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22990124 ↗MalfunctionSep 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ON 22ND AUGUST 2025, RAYNER RECEIVED NOTIFICATION FROM A US HEALTHCARE FACILITY OF AN EVENT THAT OCCURRED FOLLOWING IMPLANTATION OF A RAYONE SPHERIC RAO100C. THE EVENT DESCRIPTION PROVIDED STATES THAT POST-OPERATIVELY THE PATIENT HAS EXPERIENCED PERSISTENT NEGATIVE DYSPHOTOPSIA NECESSITATING ADDITIONAL SURGERY TO EXPLANT AND EXCHANGE THE LENS.
Patient problems: Visual Disturbances; Visual Impairment
MAUDE report 22976119 ↗
Other Rayner Intraocular Lenses Limited products
All Rayner Intraocular Lenses Limited devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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