Precision Ideal Eyes 0502103010Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 07613327062083), received between Oct 13, 2020 and Sep 8, 2023 — classified as 2 injuries, 12 malfunctions.

The most frequently reported specific device problem is “Poor Quality Image” (11 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 8, 2023Poor Quality Image; Poor Quality Image

  IT WAS REPORTED THAT THERE WAS BLURRY IMAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17715556 ↗
• MalfunctionSep 8, 2023Poor Quality Image; Poor Quality Image

  IT WAS REPORTED THAT THERE WAS BLURRY IMAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17715478 ↗
• MalfunctionAug 16, 2023Poor Quality Image; Poor Quality Image

  IT WAS REPORTED THAT THERE WAS POOR IMAGE QUALITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17560385 ↗
• MalfunctionAug 16, 2023Poor Quality Image; Poor Quality Image

  IT WAS REPORTED THAT THERE WAS POOR IMAGE QUALITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17560382 ↗
• MalfunctionAug 16, 2023Poor Quality Image; Poor Quality Image

  IT WAS REPORTED THAT THERE WAS POOR IMAGE QUALITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17560381 ↗
• MalfunctionAug 16, 2023Poor Quality Image; Poor Quality Image

  IT WAS REPORTED THAT THERE WAS POOR IMAGE QUALITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17560379 ↗
• MalfunctionAug 16, 2023Poor Quality Image; Poor Quality Image

  IT WAS REPORTED THAT THERE WAS POOR IMAGE QUALITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17560377 ↗
• MalfunctionAug 16, 2023Poor Quality Image; Poor Quality Image

  IT WAS REPORTED THAT THERE WAS POOR IMAGE QUALITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17560376 ↗
• MalfunctionAug 16, 2023Poor Quality Image; Poor Quality Image

  IT WAS REPORTED THAT THERE WAS POOR IMAGE QUALITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17560373 ↗
• MalfunctionMay 9, 2023Poor Quality Image; Poor Quality Image

  IT WAS REPORTED THAT THERE WAS BLURRY IMAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16898774 ↗
• InjuryFeb 6, 2023Fracture

  IT WAS REPORTED THAT THE LIP LENS WAS FRACTURED AND THE POTENTIAL OF THE PIECES BEING LEFT IN THE PATIENT.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16308866 ↗
• MalfunctionMar 21, 2022Poor Quality Image; Optical Problem; Optical Problem

  IT WAS REPORTED THAT THERE WAS A POTENTIAL OF ADVERSE EVENT DUE TO FOGGY IMAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13839354 ↗
• MalfunctionMar 31, 2021Fogging; Optical Problem; Fogging; Optical Problem

  IT WAS REPORTED THAT THERE WAS FOGGY IMAGE DURING THE PROCEDURE.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 11598044 ↗
• InjuryOct 13, 2020Material Fragmentation; Material Fragmentation; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PIECE WAS LEFT INSIDE THE BODY OF THE PATIENT.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 10671878 ↗