CART45SRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00844369018975), received between Sep 17, 2025 and Sep 17, 2025 — classified as 3 injuries.

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

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjurySep 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LENSTEC RECEIVED AN EMAIL STATING, "WHITE FILM ON LENSES NOTED ON MULTIPLE PATIENTS, NO SERIAL NUMBERS".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23077912 ↗
• InjurySep 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LENSTEC RECEIVED AN EMAIL STATING, "WHITE FILM ON LENSES NOTED ON MULTIPLE PATIENTS, NO SERIAL NUMBERS."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23077911 ↗
• InjurySep 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LENSTEC RECEIVED AN EMAIL STATING, "WHITE FILM ON LENSES NOTED ON MULTIPLE PATIENTS, NO SERIAL NUMBERS".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23077910 ↗