ORA System® VerifEye™ 8065753001Recalls & reported problems
Alcon Laboratories, Inc. · ORA System with VerifEyeTM Lynk, Aberrometer 195.5 · Class 1
All models of ORA System VerifEye (6)
Data updated Oct 18, 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 00380657530014), received between Jul 15, 2024 and Jul 15, 2024 — classified as 1 injury.
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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Visual Impairment1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJul 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT AN EXPLANTED INTRAOCULAR LENS DUE TO A MYOPIC REFRACTIVE OUTCOME WAS GREATER THAN TWO DIOPTERS IN THE PATIENT'S UNKNOWN EYE AFTER SURGERY.
Patient problems: Visual Impairment
MAUDE report 19739076 ↗
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™ 8065753003Alcon 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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