ACS CMEY17AIRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00191072211514), received between Apr 21, 2025 and Apr 21, 2025 — classified as 1 injury.

The most frequently reported specific device problem is “Contamination” (1 report).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Sep 4, 2025Class IIOpen, Classified

   Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the initial Ethylene Oxide (EO) gas injection process. These products have not been validated for exposure to multiple sterilization cycles. Therefore, product quality, safety, and effectiveness cannot be confirmed for product that was re-gassed.

   Z-0185-2026 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryApr 21, 2025Contamination; Contamination

  THE CUSTOMER STATES MULTIPLE PIECES OF BLACK MATERIAL, POSSIBLY INK, WAS COMING OFF LABELS ONTO SURGEON'S GLOVES DURING AN IMPLANT PROCEDURE. THE PRODUCT WAS USED DURING IOL IMPLANT PROCEDURE AND WAS NOT NOTICED UNTIL DEBRIS WAS SEEN IN THE EYE BY THE SURGEON. THE DEBRIS WAS REMOVED FROM PATIENT'S EYE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21876493 ↗