ORA System® VerifEye™ 8065753003Recalls & reported problems
Alcon Laboratories, Inc. · ORA System with VerifEyeTM Lynk, Cart · Class 1
All models of ORA System VerifEye (6)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00380657530038), received between Apr 5, 2021 and Apr 5, 2021 — classified as 1 injury.
The most frequently reported specific device problem is “Incorrect Measurement” (1 report).
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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Incorrect Measurement1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryApr 5, 2021Incorrect Measurement; Incorrect Measurement
A SURGEON REPORTED A DEVIATION IN AXIS WAS DISCOVERED DURING A SCAN FOLLOWING A CATARACT PROCEDURE. THE PATIENT WAS OPERATED ON AGAIN TO CORRECT THE AXIS. A 15 DEGREE DEVIATION IN TORIC AXIS WAS NOTED BETWEEN THE FIRST AND SECOND PROCEDURES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11615675 ↗
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™ 8065998330Alcon Laboratories, Inc. · Aberrometer, ophthalmic7 reports
- ORA System® VerifEye™ 8065753001Alcon Laboratories, Inc. · Aberrometer, ophthalmic1 report
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- 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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