ORA System® VerifEye™ 8065753093Recalls & reported problems
Alcon Laboratories, Inc. · ORA System with VerifEyeTM+ 2.0, Cart · Class 1
- Adverse event reports
- 18
- Deaths reported
- 0
- Injuries reported
- 6
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00380657530939), received between Jul 31, 2021 and Jun 28, 2026 — classified as 6 injuries, 12 malfunctions.
The most frequently reported specific device problem is “Incorrect Measurement” (9 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, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Incorrect Measurement9
- Incorrect, Inadequate or Imprecise Result or Readings5
- Adverse Event Without Identified Device or Use Problem2
- Loose or Intermittent Connection2
Patient problems
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available6
- Insufficient Information6
- Blurred Vision5
- No Clinical Signs, Symptoms or Conditions4
- Visual Disturbances4
- Visual Impairment2
- Corneal Edema1
- Dry Eye(s)1
Recent adverse event reports
The 18 most recent of 18 reports, in the reporter's own words as published by the FDA.
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 ↗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 ↗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 ↗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 ↗InjuryJun 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A NON HEALTHCARE PROFESSIONAL REPORTED UNEXPECTED OUTCOME ALONG WITH HAZY, BLURRY VISION, HALOS, GLARES DUE TO THE SYSTEM IN THE RIGHT EYE AFTER CATARACT SURGERY. THE PATIENT TAKEN PRESCRIBED MEDICATIONS SUCH AS KETOROLAC, PRED FORTE, TOBRAMYCIN EYE DROPS FOR TREATMENT. THE VISION HAS IMPROVED. 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: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Blurred Vision; Visual Disturbances
MAUDE report 22349506 ↗InjuryJun 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A NON-HEALTHCARE PROFESSIONAL REPORTED UNEXPECTED OUTCOME ALONG WITH HAZY, BLURRY VISION, HALOS, GLARES DUE TO THE SYSTEM IN THE LEFT EYE AFTER CATARACT SURGERY. THE PATIENT TAKEN PRESCRIBED MEDICATIONS SUCH AS KETOROLAC, PRED FORTE, TOBRAMYCIN EYE DROPS FOR TREATMENT. THE VISION HAS IMPROVED. THERE ARE TWO RELATED REPORTS FOR THIS PATIENT. THIS REPORT ADDRESSES THE PATIENT'S LEFT EYE AND ANOTHER MANUFACTURER REPORT WILL BE FILED FOR THE FELLOW EYE.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Blurred Vision; Visual Disturbances
MAUDE report 22349464 ↗MalfunctionApr 22, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
THE HEALTHCARE PROFESSIONAL REPORTED THAT THE SURGEON REPORTED THAT THE CYLINDRICAL AND AXIS MEASUREMENTS WERE OFF BY A COUPLE DIOPTERS DURING APHAKIC MEASUREMENTS IN THE UNKNOWN EYE OF A PATIENT, DURING SURGERY.
Patient problems: Insufficient Information
MAUDE report 21878947 ↗InjuryNov 28, 2024Incorrect Measurement; Incorrect Measurement
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT SYSTEM WITH INACCURATE LENS RECOMMENDATION RESULTED IN UNEXPECTED OUTCOMES AND EXPLANT OF THE INTRAOCULAR LENS IN THE LEFT EYE OF A PATIENT, AND PATIENT EXPERIENCED EYE IRRITATED, BLURRY ALL THE TIME AND HURTS WITH THE POST OPERATIVE BEST CORRECTED VISUAL ACUITY VALUES WERE MORE THAN ONE DIOPTER AFTER SURGERY.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Blurred Vision; Visual Disturbances
MAUDE report 20803352 ↗InjuryJul 1, 2024Incorrect Measurement; Incorrect Measurement
A HEALTHCARE PROFESSIONAL REPORTED THAT THE SYSTEM WITH INACCURATE MEASUREMENTS AND INTRAOCULAR LENS WAS EXPLANTED DUE TO PATIENT HAD ASTIGMATISM IN RIGHT EYE OF A PATIENT. THE LENS WAS REPLACED WITH ADVANCED TECHNOLOGY INTRAOCULAR LENS. THE SURGEON TOOK THE READING, AND THE MEASUREMENT WAS MISLEADING.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 19642556 ↗MalfunctionFeb 13, 2024Incorrect Measurement; Incorrect Measurement
A HEALTHCARE PROFESSIONAL REPORTED THAT THE SYSTEM WAS MEASURING SPHERICAL BUT NOT MEASURING CYLINDER. THE SELECTION FOR ASTIGMATISM DID NOT EXIST FOR THE PATIENT. THERE WAS NO RED FIXATION LIGHT ON THE SCREEN DURING UNKNOWN PROCEDURE.
Patient problems: Insufficient Information
MAUDE report 18695227 ↗MalfunctionJan 11, 2024Incorrect Measurement; Incorrect Measurement
A HEALTHCARE PROFESSIONAL REPORTED A SYSTEM WITH DIFFICULTY DETERMINING THE SPHERE AND PLACING THE INTRAOCULAR LENS DURING AN UNSPECIFIED TIMING OF THE SURGERY IN AN UNKNOWN EYE.
Patient problems: Insufficient Information
MAUDE report 18490844 ↗MalfunctionMar 6, 2023Incorrect Measurement; Incorrect Measurement
A HEALTHCARE PROFESSIONAL REPORTED A PATIENT WITH BLURRY VISION IN THE LEFT EYE. ADDITIONAL INFORMATION RECEIVED THAT SYSTEM PROVIDED INCONSISTENT MEASUREMENTS. PATIENT SYMPTOMS WERE RESOLVED.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 16486193 ↗MalfunctionDec 22, 2022Incorrect Measurement; Incorrect Measurement
A CUSTOMER REPORTED AN UNEXPECTED OUTCOME AND SIGNIFICANTLY DIFFERENT POWER IN THE UNKNOWN EYE OF A PATIENT, DURING SURGERY.
Patient problems: Insufficient Information
MAUDE report 16034054 ↗MalfunctionDec 22, 2022Incorrect Measurement; Incorrect Measurement
IN A JOURNAL ARTICLE, A CUSTOMER REPORTED DEVICE COULD NOT MEASURE INTRAOPERATIVE REFRACTION DESPITE ABSENCE OF OCULAR COMORBIDITIES IN THE UNKNOWN EYE OF A PATIENT.
Patient problems: Insufficient Information
MAUDE report 16033744 ↗MalfunctionMar 21, 2022Loose or Intermittent Connection; Loose or Intermittent Connection
A FACILITY REPRESENTATIVE REPORTED LOOSE DOVETAIL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13840483 ↗MalfunctionMar 21, 2022Incorrect Measurement; Incorrect Measurement
A CUSTOMER REPORTED ISSUES WITH TORIC READINGS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13839756 ↗MalfunctionFeb 21, 2022Incorrect Measurement; Incorrect Measurement
A NON-HEALTHCARE PROFESSIONAL REPORTED A PATIENT ISSUES WITH THE DEVICE NOT OFFERING READINGS.
Patient problems: Insufficient Information
MAUDE report 13569841 ↗MalfunctionJul 31, 2021Loose or Intermittent Connection; Loose or Intermittent Connection
A CUSTOMER REPORTED DOVETAIL BROKEN TO ANOTHER ATTACHMENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12257173 ↗
Other Aberrometer, ophthalmic devices
- ORA System® VerifEye™ 8065998329Alcon Laboratories, Inc. · Aberrometer, ophthalmic17 reports
- ORA System® VerifEye™ 8065998328Alcon Laboratories, Inc. · Aberrometer, ophthalmic11 reports
- ORA System® VerifEye™ 8065998330Alcon Laboratories, Inc. · Aberrometer, ophthalmic7 reports
- ORA System® VerifEye™ 8065753001Alcon Laboratories, Inc. · Aberrometer, ophthalmic1 report
- ORA System® VerifEye™ 8065753003Alcon Laboratories, Inc. · Aberrometer, ophthalmic1 report
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.