ORA System® VerifEye™ 8065998329Recalls & reported problems
Alcon Laboratories, Inc. · ORA System with VerifEye + Technology, Abberometer 184.5mm Transient, non-invasive, active therapeutic device, intended for diagnosis and monitoring in ophthalmic surgical procedure. · Class 1
- Adverse event reports
- 17
- Deaths reported
- 0
- Injuries reported
- 9
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00380659983290), received between Jun 5, 2024 and Aug 27, 2026 — classified as 9 injuries, 8 malfunctions.
The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (13 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, Inadequate or Imprecise Result or Readings13
- Incorrect Measurement2
- Adverse Event Without Identified Device or Use Problem1
- Failure to Align1
- Nonstandard Device1
Patient problems
- Insufficient Information6
- Blurred Vision5
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available4
- Visual Impairment3
- No Clinical Signs, Symptoms or Conditions2
- Diplopia/Double Vision1
- Visual Disturbances1
Recent adverse event reports
The 17 most recent of 17 reports, 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 ↗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 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 ↗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 ↗InjuryJun 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A PHYSICIAN REPORTED THAT PATIENT EXPERIENCED HIGH CYLINDER AND TOO MUCH RESIDUAL ASTIGMATISM. THE SYSTEM SHOWED NEURO RETINAL RIM POST OPERATIVELY RIGHT EYE AFTER CATARACT SURGERY. THE SURGEON WAS ATTEMPTING IMPROVEMENT WITH PILOCARPINE DROPS AS PER THE COMPANY REPRESENTATIVE.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 22139303 ↗MalfunctionMay 11, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT SYSTEM MEASUREMENTS ARE OFF IN THE UNKNOWN EYE DURING CATARACT SURGERY. THE SURGEON REPORTED THAT THERE IS NO UNEXPECTED OUTCOMES OCCURRED. HE WENT WITH PRE-OPERATIVE TREATMENT VALUES.
Patient problems: Insufficient Information
MAUDE report 21999832 ↗InjuryMay 6, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
A NURSE REPORTED THAT LENS MOVED BACK DURING INTRAOCULAR LENS IMPLANTATION RESULTED IN POOR VISION IN THE RIGHT EYE OF THE PATIENT AFTER CATARACT SURGERY.
Patient problems: Visual Impairment
MAUDE report 21970724 ↗InjuryMar 7, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
A NURSE REPORTED IN AN INACCURATE CALCULATIONS RESULTED IN AN EXPLANTED INTRAOCULAR LENS IN THE LEFT EYE OF THE PATIENT DURING CATARACT SURGERY.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 21549252 ↗InjuryFeb 25, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
A NON-HEALTHCARE PROFESSIONAL REPORTED EXPLANT INTRAOCULAR LENS DUE TO INCORRECT LENS POWER CALCULATIONS BY THE SYSTEM IN THE UNKNOWN EYE OF THE PATIENT, WITH NO PRE- AND POST-OPERATIVE RESULTS AFTER CATARACT SURGERY.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 21458140 ↗InjuryNov 28, 2024Incorrect Measurement; Incorrect Measurement
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT WITH INACCURATE LENS RECOMMENDATION RESULTED IN UNEXPECTED OUTCOMES AND EXPLANT OF THE INTRAOCULAR LENS IN THE LEFT EYE OF A PATIENT, AND PATIENT HAD 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 20803351 ↗MalfunctionNov 14, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT A MEASUREMENT OFF IN THE UNKNOWN EYE OF A PATIENT, TIMING WAS UNKNOWN. THERE WERE NO PATIENT IMPACT WITH REPORTED ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20682899 ↗MalfunctionJun 5, 2024Incorrect Measurement; Incorrect Measurement
A CUSTOMER REPORTED THAT AN INACCURATE MEASUREMENT RESULTED IN THE INCORRECT INTRAOCULAR LENS BEING IMPLANTED AT THE WRONG AXIS IN THE PATIENT'S RIGHT EYE, AFTER INTRAOCULAR LENS IMPLANTATION SURGERY.
Patient problems: Insufficient Information
MAUDE report 19467390 ↗
Other Aberrometer, ophthalmic devices
- ORA System® VerifEye™ 8065753093Alcon Laboratories, Inc. · Aberrometer, ophthalmic18 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.