ORA System® VerifEye™ 8065998330Recalls & reported problems
Alcon Laboratories, Inc. · ORA System with VerifEye + Technology , Abberometer 195.5mm Transient, non-invasive, active therapeutic device, intended for diagnosis and monitoring in ophthalmic surgical procedure. · Class 1
- Adverse event reports
- 7
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00380659983306), received between Nov 12, 2024 and Feb 13, 2026 — classified as 2 injuries, 5 malfunctions.
The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (5 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 Readings5
- Defective Component1
- Incorrect Measurement1
Patient problems
- Insufficient Information5
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available2
- Visual Impairment1
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
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 ↗MalfunctionJun 15, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
A NON HEALTHCARE PROFESSIONAL REPORTED THAT SYSTEM PROVIDED INCORRECT READINGS AND VALUES IN THE UNKNOWN EYE OF A PATIENT DURING CATARACT SURGERY.
Patient problems: Insufficient Information
MAUDE report 22208563 ↗InjuryApr 1, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
A HEALTHCARE PROFESSIONAL REPORTED THAT THE PATIENT EXPERIENCED UNEXPECTED OUTCOME DUE TO SYSTEM MEASUREMENTS IN THE LEFT EYE OF A PATIENT, AFTER LASIK SURGERY. THE MEASUREMENTS WAS DONE IN PHAKIC MODE INSTEAD OF NOT APHAKIC MEASUREMENT MODE.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 21739731 ↗MalfunctionMar 21, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
A HEALTHCARE PROFESSIONAL REPORTED THAT THE SYSTEM READING WAS DIFFERENT THAN PRE OPERATIVE MEASUREMENT VALUES IN THE RIGHT EYE OF A PATIENT, DURING CATARACT SURGERY. THERE WAS NO REPORTED UNEXPECTED OUTCOME AT THIS TIME.
Patient problems: Insufficient Information
MAUDE report 21662528 ↗InjuryFeb 21, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT THE SURGEON QUESTIONED ABOUT THE SYSTEM READINGS AND THE INTRAOCULAR LENS WAS ROTATED BY ONE HUNDRED TWENTY DEGREES, AS THE RESULT THE PATIENT HAD INDUCED ASTIGMATISM OF THREE DIOPTERS IN THE RIGHT EYE OF A PATIENT, DURING CATARACT 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: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Visual Impairment
MAUDE report 21432692 ↗MalfunctionNov 12, 2024Incorrect Measurement; Incorrect Measurement
THE HEALTHCARE PROFESSIONAL REPORTED THAT THE SYSTEM WITH WRONG READING DURING POST TORIC MEASUREMENTS IN THE UNKNOWN EYE OF A PATIENT, DURING SURGERY.
Patient problems: Insufficient Information
MAUDE report 20661110 ↗
Other Aberrometer, ophthalmic devices
- ORA System® VerifEye™ 8065753093Alcon Laboratories, Inc. · Aberrometer, ophthalmic18 reports
- ORA System® VerifEye™ 8065998329Alcon Laboratories, Inc. · Aberrometer, ophthalmic17 reports
- ORA System® VerifEye™ 8065998328Alcon Laboratories, Inc. · Aberrometer, ophthalmic11 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.