1488, Ideal Eyes 1488020125Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07613327061086), received between Nov 19, 2020 and Apr 25, 2024 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Poor Quality Image” (3 reports).

3 other recalls cover devices cleared under the same FDA submission (K132785); they may or may not involve this specific model.

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 25, 2024Optical Problem; Optical Problem

  IT WAS REPORTED THAT THERE WAS BLURRY IMAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19183445 ↗
• MalfunctionJan 25, 2024Poor Quality Image; Optical Problem; Poor Quality Image; Optical Problem

  IT WAS REPORTED THAT THERE WAS BLURRY IMAGE AND FOGGY IMAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18580556 ↗
• MalfunctionJul 22, 2022Poor Quality Image; Optical Distortion; Optical Distortion

  IT WAS REPORTED THAT THERE WAS BLURRY IMAGE. THE ORIGINAL DEVICE COULD NOT BE USED TO COMPLETE THE PROCEDURE.

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

  MAUDE report 15083615 ↗
• MalfunctionNov 19, 2020Poor Quality Image; Poor Quality Image

  IT WAS REPORTED THAT THERE WAS A BLURRY IMAGE.

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

  MAUDE report 10871278 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K132785. One submission often covers many models, so check the product and lot details in each record.

• Z-0569-2015 · Mar 5, 2013 · Terminated
  1488 HD 3-Chip Camera; Model Number 1488-210-105 - C-Mount. Product Usage: High definition camera to view endoscopic surgical sites on video monitors and capture still and video
• Z-0570-2015 · Mar 5, 2013 · Terminated
  1488 HD 3-Chip Inline Camera; Model Number 1488-710-105 - HD 3-Chip Inline Camera, C-Mount; Product Usage: High definition camera to view endoscopic surgical sites on video monit
• Z-0571-2015 · Mar 5, 2013 · Terminated
  1488 HD 3-Chip Camera; Model Number 1488-610-122 - HD 3-Chip Camera Head with Integrated Coupler. Product Usage: High definition camera to view endoscopic surgical sites on video