ORA System VerifEyeRecalls & reported problems across all models
Alcon Laboratories, Inc. · 6 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 55
- Deaths reported
- 0
- Injuries reported
- 24
- Recalls
- 0
We found 6 models of ORA System VerifEye by Alcon Laboratories, Inc. in the FDA's device registry (GUDID). Together they are named in 55 adverse event reports in the FDA's MAUDE database, received between Apr 5, 2021 and Aug 27, 2026 — classified as 24 injuries, 31 malfunctions.
The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (26 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 ORA System VerifEye problems
Device problems
- Incorrect, Inadequate or Imprecise Result or Readings26
- Incorrect Measurement21
- Adverse Event Without Identified Device or Use Problem4
- Loose or Intermittent Connection2
- Defective Component1
- Failure to Align1
- Nonstandard Device1
Patient problems
- Insufficient Information22
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available18
- Blurred Vision11
- No Clinical Signs, Symptoms or Conditions7
- Visual Impairment7
- Visual Disturbances5
- Corneal Edema1
- Diplopia/Double Vision1
ORA System VerifEye models
6 models, most reported first. Each model has its own page with its reports, recalls and device details.
- ORA System® VerifEye™ 8065753093Aberrometer, ophthalmic18 reports
- ORA System® VerifEye™ 8065998329Aberrometer, ophthalmic17 reports
- ORA System® VerifEye™ 8065998328Aberrometer, ophthalmic11 reports
- ORA System® VerifEye™ 8065998330Aberrometer, ophthalmic7 reports
- ORA System® VerifEye™ 8065753001Aberrometer, ophthalmic1 report
- ORA System® VerifEye™ 8065753003Aberrometer, ophthalmic1 report
Recent ORA System VerifEye adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryAug 27, 2026Incorrect, Inadequate or Imprecise Result or Readings
A non-healthcare professional reported that the patient experienced double vision, blurry vision in the left eye, and an explant intraocular lens due to inaccurate measurements provided by the system during intraocular lens selection, after refractive surgery.
Patient problems: Blurred Vision; Diplopia/Double Vision
MAUDE report 50478925 ↗MalfunctionAug 13, 2026Nonstandard Device
Patient problems: Insufficient Information
MAUDE report 50232378 ↗InjuryJul 2, 2026Incorrect, Inadequate or Imprecise Result or Readings
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT AN INTRAOCULAR LENS WAS EXPLANTED DUE TO SYSTEM-SUGGESTED INCORRECT READINGS OR MEASUREMENTS. THE PATIENT EXPERIENCED BLURRY DISTANCE VISION AND A REFRACTIVE SURPRISE, RESULTING IN RESIDUAL ASTIGMATISM IN THE RIGHT EYE. AND THE BEST-CORRECTED POSTOPERATIVE VISUAL ACUITY (BCVA) WAS LESS THAN THE EXPECTED REFRACTIVE OUTCOME, AFTER REFRACTIVE SURGERY. THERE ARE MULTIPLE RELATED REPORTS FOR THIS FACILITY. THIS REPORT ADDRESSES PATIENT¿S INITIALS (B)(6), RIGHT EYE AND OTHER MANUFACTURER REPORTS WILL BE FILED.
Patient problems: Blurred Vision; Visual Impairment
MAUDE report 25692455 ↗MalfunctionJun 28, 2026Incorrect, Inadequate or Imprecise Result or Readings
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT PATIENT EXPERIENCED REFRACTIVE SURPRISE DUE TO MISS CALCULATION IN THE RIGHT EYE AFTER REFRACTIVE SURGERY. THERE ARE TWO RELATED REPORTS FOR THIS PATIENT. THIS REPORT ADDRESSES THE PATIENT'S RIGHT EYE AND ANOTHER MANUFACTURER REPORT WILL BE FILED FOR THE FELLOW EYE.
Patient problems: Visual Impairment
MAUDE report 25648372 ↗InjuryFeb 25, 2026Incorrect, Inadequate or Imprecise Result or Readings
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT THIS REPORT OF AN INTRAOCULAR LENS WAS EXPLANTED AFTER THE PATIENT EXPERIENCED BLURRY VISION IN THE UNKNOWN EYE DUE TO UNEXPECTED POSTOPERATIVE RESULTS, WHICH WERE ATTRIBUTED TO THE SYSTEM SUGGESTING AN INACCURATE INTRAOCULAR LENS POWER DURING REFRACTIVE SURGERY.
Patient problems: Blurred Vision; Visual Impairment
MAUDE report 24440422 ↗MalfunctionFeb 20, 2026Incorrect, Inadequate or Imprecise Result or Readings
A NON-HEALTHCARE PROFESSIONAL REPORTED SYSTEM WITH AXIS READINGS WERE OFF FOR THE UNKNOWN EYE OF THE PATIENT DURING REFRACTIVE SURGERY. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Insufficient Information
MAUDE report 24398241 ↗MalfunctionFeb 19, 2026Incorrect, Inadequate or Imprecise Result or Readings; Failure to Align
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT SYSTEM MEASUREMENTS SEEM TO BE OUT OF ALIGNMENT AND SHOWED INCORRECT VALUES/ READINGS IN THE UNKNOWN EYE IN THE UNKNOWN TIMINGS OF THE SURGERY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 24385960 ↗MalfunctionFeb 18, 2026Incorrect, Inadequate or Imprecise Result or Readings
A NON-HEALTHCARE PROFESSIONAL REPORTED SYSTEM PROVIDED CALCULATIONS WHICH WERE OFF IN THE LEFT EYE OF THE PATIENT AS A RESULT LENS POWER CAME OUT WRONG AFTER REFRACTIVE SURGERY, POST THE PATIENT EXPERIENCED GLARES, CORNEAL EDEMA, MILD ASTIGMATISM, DRYNESS, ITCHINESS, EYE PAIN. FURTHER, THE INTRAOCULAR LENS WAS EXPLANTED. THERE WAS NO PATIENT HARM AND MEDICAL INTERVENTION REPORTED ADDITIONALLY.
Patient problems: Blurred Vision; Corneal Edema; Dry Eye(s); Eye Irritation; Eye Pain; No Clinical Signs, Symptoms or Conditions; Visual Disturbances; Visual Impairment
MAUDE report 24379018 ↗MalfunctionFeb 13, 2026Defective Component
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT RESIGHT DOVETAIL ON ABERROMETER WAS BROKEN IN THE UNKNOWN EYE IN THE UNKNOWN TIMING.
Patient problems: Insufficient Information
MAUDE report 24332588 ↗MalfunctionFeb 6, 2026Incorrect, Inadequate or Imprecise Result or Readings
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT THE SYSTEM READINGS WERE OFF IN THE UNKNOWN EYE DURING UNKNOWN TIMING OF THE REFRACTIVE SURGERY.
Patient problems: Insufficient Information
MAUDE report 24275490 ↗MalfunctionFeb 4, 2026Incorrect, Inadequate or Imprecise Result or Readings
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT THE READINGS WAS OFF IN THE UNKNOWN EYE OF A PATIENT, DURING REFRACTIVE SURGERY. SURGEON WENT WITH PRE-OPERATIVE PLAN. THERE WERE NO REPORTED ISSUES WITH THE PATIENT OUTCOMES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24255925 ↗InjuryDec 4, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT PATIENT EXPERIENCED RESIDUAL REFRACTION ERROR DUE TO LENS MISALIGNMENT OR DISPLACEMENT AND THE SURGEON REPORTED THAT THE SYSTEM RECOMMENDED INACCURATE MEASUREMENT. THE LENS WAS EXPLANTED AND REPLACED WITH ADVANCED TECHNOLOGY INTRAOCULAR LENS.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 23717795 ↗InjuryNov 28, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
A NURSE REPORTED THAT AN EXPLANTED INTRAOCULAR LENS DUE TO INCORRECT TORIC CORRECTION LENS SUGGESTED BY THE SYSTEM, WHICH RESULTED IN BLURRED VISION IN THE PATIENT¿S RIGHT EYE AFTER REFRACTIVE SURGERY.
Patient problems: Blurred Vision
MAUDE report 23671060 ↗MalfunctionNov 25, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT SYSTEM MEASURING ONE DIOPTER WAS OFF IN UNKNOWN EYE DURING UNKNOWN TIMING OF REFRACTIVE SURGERY.
Patient problems: Insufficient Information
MAUDE report 23645297 ↗InjuryJul 30, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
A HEALTHCARE PROFESSIONAL REPORTED THAT THE INTRAOCULAR LENS WAS EXPLANTED AND REPLACED. THE PATIENT HAD POST HYPEROPIC LASIK ENHANCEMENT, POST PTERYGIUM, AND HAD IMPLANTABLE COLLAMER LENS TOUCHING NATURAL LENS THAT CAUSED THE CATARACT. THE SYSTEM SUGGESTED INACCURATE MEASUREMENTS THAT LEADS TO RESIDUAL ASTIGMATISM AND BLURRY VISION WITH POST OPERATIVE BEST CORRECTED VISUAL ACUITY VALUES WERE MORE THAN TWO DIOPTERS IN THE LEFT EYE OF THE PATIENT AFTER CATARACT SURGERY.
Patient problems: Blurred Vision
MAUDE report 22666805 ↗
Other Alcon Laboratories, Inc. products
- Clareon1,142 models · 8,100 reports · 1 recall
- Constellation, EDGE PLUS, TOTAL PLUS, ULTRAVIT8 models · 2,968 reports · 5 recalls
- Constellation13 models · 2,176 reports · 4 recalls
- CONSTELLATION HYPERVIT TOTAL PLUS5 models · 2,098 reports · 4 recalls
- Centurion5 models · 1,967 reports
- ACRYSOF353 models · 1,890 reports
- AcrySof UltraSert102 models · 1,467 reports · 1 recall
- MONARCH III2 models · 1,380 reports · 1 recall
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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