RayOne EMVRecalls & reported problems across all models
Rayner Intraocular Lenses Limited · 16 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names at least one RayOne EMV model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 43
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 1
We found 16 models of RayOne EMV by Rayner Intraocular Lenses Limited in the FDA's device registry (GUDID). Together they are named in 43 adverse event reports in the FDA's MAUDE database, received between May 24, 2021 and Aug 25, 2026 — classified as 43 malfunctions.
The most frequently reported specific device problem is “Manufacturing, Packaging or Shipping Problem” (8 reports).
1 FDA recall record name at least one of these models by its device identifier, 1 still open.
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
RayOne EMV recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- May 13, 2022Open, Classified
The outer package is mislabeled and the package contains a different IOL strength.
Z-1338-2022 · Root cause: Under Investigation by firm · names 2 of these models · Recall details · FDA record ↗
Most reported RayOne EMV problems
Device problems
- Adverse Event Without Identified Device or Use Problem9
- Manufacturing, Packaging or Shipping Problem8
- Break7
- Material Split, Cut or Torn4
- Optical Problem3
- Crack2
- Failure to Eject2
- Insufficient Device Problem Information2
Patient problems
- No Clinical Signs, Symptoms or Conditions18
- Visual Impairment17
- Capsular Bag Tear3
- Toxic Anterior Segment Syndrome (TASS)3
- Inflammation2
- Visual Disturbances2
- Endophthalmitis1
- Insufficient Information1
RayOne EMV models
16 models, most reported first. Each model has its own page with its reports, recalls and device details.
- RayOne EMV RAO200EIntraocular Lens1 recall15 reports
- RayOne EMV RAO200EIntraocular Lens1 recall2 reports
- RayOne EMV RAO200EIntraocular Lens4 reports
- RayOne EMV RAO200EIntraocular Lens4 reports
- RayOne EMV RAO200EIntraocular Lens4 reports
- RayOne EMV RAO200EIntraocular Lens2 reports
- RayOne EMV RAO200EIntraocular Lens2 reports
- RayOne EMV RAO200EIntraocular Lens2 reports
- RayOne EMV RAO200EIntraocular Lens1 report
- RayOne EMV RAO200EIntraocular Lens1 report
- RayOne EMV RAO200EIntraocular Lens1 report
- RayOne EMV RAO200EIntraocular Lens1 report
- RayOne EMV RAO200EIntraocular Lens1 report
- RayOne EMV RAO200EIntraocular Lens1 report
- RayOne EMV RAO200EIntraocular Lens1 report
- RayOne EMV RAO200EIntraocular Lens1 report
Recent RayOne EMV adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionAug 25, 2026Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50422502 ↗MalfunctionMay 5, 2026Material Integrity Problem
ON 21ST APRIL 2026, RAYNER RECEIVED NOTIFICATION FROM A US HEALTHCARE FACILITY OF AN EVENT THAT OCCURRED DURING USE OF A RAYONE EMV RAO200E. THE EVENT DESCRIPTION PROVIDED STATES THAT IMMEDIATELY FOLLOWING IMPLANTATION THERE WAS AN IMPERFECTION IN THE CENTRE OF THE LENS NECESSITATING LENS EXPLANTATION AND EXCHANGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25079424 ↗MalfunctionApr 9, 2026Optical Problem
ON 27TH MARCH 2026, RAYNER RECEIVED NOTIFICATION FROM A US HEALTHCARE FACILITY OF AN EVENT THAT OCCURRED FOLLOWING IMPLANTATION OF A RAYONE EMV RAO200E. THE EVENT DESCRIPTION PROVIDED STATES THAT THE PATIENT WAS DISSATISFIED WITH THEIR POST-OPERATIVE VISION AND ELECTED TO UNDERGO AN ADDITIONAL SURGERY TO EXPLANT AND EXCHANGE THE LENS.
Patient problems: Visual Impairment
MAUDE report 24829733 ↗MalfunctionApr 9, 2026Scratched Material
ON 27TH MARCH 2026, RAYNER RECEIVED NOTIFICATION FROM A US HEALTHCARE FACILITY OF AN EVENT THAT OCCURRED DURING USE OF A RAYONE EMV RAO200E. THE EVENT DESCRIPTION PROVIDED STATES THAT IMMEDIATELY FOLLOWING IMPLANTATION INTO THE EYE THE LENS WAS SCRATCHED NECESITATING LENS EXPLANTATION AND EXCHANGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24829731 ↗MalfunctionApr 9, 2026Optical Problem
ON 27TH MARCH 2026, RAYNER RECEIVED NOTIFICATION FROM A US HEALTHCARE FACILITY OF AN EVENT THAT OCCURRED FOLLOWING IMPLANTATION OF A RAYONE EMV RAO200E. THE EVENT DESCRIPTION PROVIDED STATES THAT THE PATIENT WAS DISSATISFIED WITH THEIR POST-OPERATIVE VISION AND ELECTED TO UNDERGO AN ADDITIONAL SURGERY TO EXPLANT AND EXCHANGE THE LENS.
Patient problems: Visual Impairment
MAUDE report 24829730 ↗MalfunctionNov 28, 2025Crack; Crack
ON 18TH NOVEMBER 2025, RAYNER RECEIVED NOTIFICATION FROM A US HEALTHCARE FACILITY OF AN EVENT THAT OCCURRED DURING USE OF A RAYONE EMV RAO200E. THE EVENT DESCRIPTION PROVIDED STATES THAT IMMEDIATELY AFTER IMPLANTATION IN THE EYE THE SURGEON OBSERVED A CRACK IN THE IOL NECESSITATING LENS EXPLANTATION AND EXCHANGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23670431 ↗MalfunctionNov 24, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
ON 4TH NOVEMBER 2025, RAYNER RECEIVED NOTIFICATION FORM A US HEALTHCARE FACILITY OF AN EVENT THAT OCCURRED DURING USE OF A RAYONE EMV RAO200E. WHILE NO EVENT DESCRIPTION IS GIVEN, THE REPORT STATES THAT LENS EXPLANTATION (REASON UNSPECIFIED) WAS REQUIRED AND THAT SURGERY WAS PROLONGED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23628965 ↗MalfunctionOct 24, 2025Break; Break
ON 10TH OCTOBER 2025, RAYNER RECEIVED NOTIFICATION FROM A HEALTHCARE FACILITY IN POLAND OF AN EVENT THAT OCCURRED DURING USE OF A RAYONE EMV RAO200E. THE EVENT DESCRIPTION PROVIDED STATES THAT IMMEDIATELY FOLLOWING IMPLANTATION INTO THE EYE THE HAPTIC WAS OBSERVED TO BE BROKEN NECESSITATING LENS EXPLANTATION AND EXCHANGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23377147 ↗MalfunctionOct 24, 2025Crack; Crack
ON 2ND OCTOBER 2025, RAYNER RECEIVED NOTIFICATION FROM ITS TAIWAN DISTRIBUTOR OF AN EVENT THAT OCCURRED DURING USE OF A RAYONE EMV RAO200E. THE EVENT DESCRIPTION PROVIDED STATES THAT IMMEDIATELY FOLLOWING IMPLANTATION INTO THE EYE A CRACK WAS OBSERVED IN THE OPTIC NECESSITATING LENS EXPLANTATION AND EXCHANGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23377144 ↗MalfunctionOct 1, 2025Insufficient Device Problem Information; Material Split, Cut or Torn; Insufficient Device Problem Information; Material Split, Cut or Torn
ON 18TH SEPTEMBER 2025, RAYNER RECEIVED NOTIFICATION FROM A US HEALTHCARE PROFESSIONAL OF AN EVENT THAT OCCURRED DURING USE OF A RAYONE EMV RAO200E. THE EVENT DESCRIPTION PROVIDED STATES THAT THE LENS SPLIT DURING INJECTION NECESSITATING LENS EXPLANTATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23189231 ↗MalfunctionAug 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ON 11TH AUGUST 2025, RAYNER RECEIVED NOTIFICATION FROM A US HEALTHCARE FACILITY OF AN EVENT THAT OCCURRED DURING USE OF A RAYONE EMV RAO200E. THE EVENT DESCRIPTION PROVIDED STATES THAT POST-OPERATIVELY THE PATIENT EXPERIENCED VISUAL IMPAIRMENT/VISUAL DISTURBANCES PROMPTING AN ADDITIONAL SURGERY TO EXPLANT AND EXCHANGE THE IOL.
Patient problems: Visual Disturbances; Visual Impairment
MAUDE report 22848633 ↗MalfunctionJul 21, 2025Failure to Eject; Failure to Eject
ON 9TH JULY 2025, RAYNER RECEIVED NOTIFICATION FROM A US HEALTHCARE FACILITY OF AN EVENT THAT OCCURRED DURING USE OF A RAYONE EMV RAO200E. THE EVENT DESCRIPTION PROVIDED STATES THAT THE LENS DID NOT DEPLOY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22554164 ↗MalfunctionMay 28, 2025Optical Problem; Optical Problem
ON 15TH MAY 2025, RAYNER RECEIVED NOTIFICATION FROM A US HEALTHCARE FACILITY OF AN EVENT THAT OCCURRED DURING USE OF A RAYONE EMV RAO200E. THE EVENT DESCRIPTION PROVIDED STATES THAT THE PATIENT REFRACTIVE OUTCOME WAS NOT AS EXPECTED POST-OPERATIVELY NECESSITATING AN ADDITIONAL SURGERY TO EXPLANT AND EXCHANGE THE IOL.
Patient problems: Visual Impairment
MAUDE report 22094781 ↗MalfunctionJan 22, 2025Break; Break
ON 13TH JANUARY 2025, RAYNER RECEIVED NOTIFICATION FROM A US HEALTHCARE FACILITY OF AN EVENT THAT OCCURRED DURING USE OF A RAYONE EMV RAO200E. THE EVENT DESCRIPTION PROVIDED STATES THAT THE TRAILING HAPTIC BROKE DURING IMPLANTATION NECESSITATING EXPLANTATION OF THE IOL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21206730 ↗MalfunctionDec 11, 2024Optical Distortion; Optical Distortion
ON 5TH DECEMBER 2024, RAYNER RECEIVED NOTIFICATION FROM A US HEALTHCARE PROFESSIONAL OF AN EVENT THAT OCCURRED FOLLOWING IMPLANTATION OF A RAYONE EMV RAO200E. THE EVENT DESCRIPTION PROVIDED STATES THAT THE PATIENT'S POST-OPERATIVE REFRACTIVE OUTCOME WAS NOT AS EXPECTED.
Patient problems: Visual Impairment
MAUDE report 20901515 ↗
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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