ORA System® VerifEye™ 8065998328Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00380659983283), received between Aug 1, 2022 and May 23, 2025 — classified as 5 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Incorrect Measurement” (8 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.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 23, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT SYSTEM HAD DIFFICULTY IN MEASURING THE EYES DURING CATARACT SURGERY.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 22080645 ↗
• InjuryMar 27, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A NON-HEALTHCARE PROFESSIONAL REPORTED SYSTEM PROVIDED INCONSISTENT MEASUREMENTS RESULTED IN AN INTRAOCULAR LENS EXCHANGE IN THE UNKNOWN EYE OF THE PATIENT DURING CATARACT SURGERY.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 21710560 ↗
• InjuryMar 27, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A NURSE THAT REPORTED A SYSTEM PROVIDED INCONSISTENT MEASUREMENTS RESULTED IN AN INTRAOCULAR LENS EXCHANGE IN THE UNKNOWN EYE OF THE PATIENT DURING CATARACT SURGERY.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 21709177 ↗
• InjuryJan 14, 2025Incorrect Measurement; Incorrect Measurement

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT THE SYSTEM WITH MEASUREMENTS WAS NOT CORRECT WHICH CAUSED BLURRED VISION AND RESULTED IN EXPLANT IN THE LEFT EYE OF A PATIENT, AFTER CATARACT SURGERY.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Blurred Vision

  MAUDE report 21150221 ↗
• MalfunctionSep 18, 2024Incorrect Measurement; Incorrect Measurement

  THE NON HEALTHCARE PROFESSIONAL REPORTED THAT THE SYSTEM WITH MEASUREMENTS WERE OFF DURING SURGERY IN THE UNKNOWN EYE OF A PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 20244642 ↗
• InjuryJun 4, 2024Incorrect Measurement; Incorrect Measurement

  A HEALTHCARE PROFESSIONAL REPORTED THAT THE INTRAOCULAR LENS WAS EXPLANTED BECAUSE OF THE WRONG LENS IMPLANTED AS PER THE SYSTEM RECOMMENDATION IN THE UNKNOWN EYE OF A PATIENT. THE ADVANCED TECHNOLOGY INTRAOCULAR LENS WAS IMPLANTED. THE SURGEON TOOK THE READING THREE TIMES DURING THE PROCEDURE AND THE SYSTEM SUGGESTED THE WRONG DIOPTER LENS TO IMPLANT. THE SURGEON IMPLANTED THE LENS WHICH WAS RECOMMENDED BY THE SYSTEM. DURING THE POST OPERATIVE VISIT, FOUND THAT THE VISION CORRECTION WAS NOT ACCURATE WITH THE LENS SELECTED. THE SURGEON EXCHANGED THE LENS OF THE PATIENT.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 19458022 ↗
• InjuryDec 8, 2023Incorrect Measurement; Incorrect Measurement

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT AN EXPLANTED INTRAOCULAR LENS WITH REASON INACCURATE POWER, UNEXPECTED OUTCOME WITH POST-OPERATIVE TREATMENT RESULTS WAS LESS THAN TWO DIOPTERS IN THE RIGHT EYE OF A PATIENT, AFTER SURGERY.

  Patient problems: Insufficient Information

  MAUDE report 18290825 ↗
• MalfunctionMay 8, 2023Incorrect Measurement; Incorrect Measurement

  A CUSTOMER REPORTED A SYSTEM PROVIDED INCORRECT VALUES AND READINGS. ADDITIONAL INFORMATION HAS BEEN RECEIVED REPORTED SURGEON ADJUSTED ACCORDING TO THEIR PLAN, NO UNEXPECTED OUTCOMES WERE REPORTED. NO ALIGNMENT ISSUE IN ABERROMETER TO CAUSE INCORRECT LENS SUGGESTIONS AND DATABASE RESET WAS PERFORMED.

  Patient problems: Insufficient Information

  MAUDE report 16886622 ↗
• MalfunctionMay 4, 2023Incorrect Measurement; Incorrect Measurement

  A HEALTH CARE PROFESSIONAL REPORTED THAT INACCURATE INTRAOCULAR LENS CALCULATION (MEASUREMENT CONCERNS ¿ PREOPERATIVE PLAN LENS, CALCULATED AND IMPLANTED LENS WAS DIFFERENT), THE LENS OVER-CORRECTED AND WILL LIKELY LEAD TO AN INTRAOCULAR LENS EXCHANGE, INTERMITTENT CART RESOLUTION ISSUES, FREEZING, TOUCH SCREEN DIFFICULTIES AND SHOWED UPSIDE DOWN ERROR MESSAGE (PHOTONI KEYNOTE), IN AN UNKNOWN EYE OF A PATIENT, DURING CATARACT SURGERY

  Patient problems: Insufficient Information

  MAUDE report 16869757 ↗
• MalfunctionDec 26, 2022Incorrect Measurement; Incorrect Measurement

  A CUSTOMER REPORTED AN EXPLANTED INTRAOCULAR LENS DUE TO BLURRY VISION, INCORRECT MEASUREMENT (MISCALCULATION) AND SPHERICAL CORRECTIONS IN THE UNKNOWN EYE OF A PATIENT, AFTER SURGERY.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 16047748 ↗
• MalfunctionAug 1, 2022Incorrect Measurement; Incorrect Measurement

  A NURSE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED BLURRED VISION. ADDITIONAL INFORMATION RECEIVED STATED RECOMMENDED A T7 AT THE INITIAL SURGERY DUE TO INCORRECT MEASUREMENTS.

  Patient problems: Insufficient Information

  MAUDE report 15139505 ↗