HEALON ENDOCOAT PRO 10300012Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05050474755093), received between Jun 5, 2026 and Jun 5, 2026 — classified as 1 malfunction.

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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Jul 31, 2026Open, Classified

   Surgical instructions sent for viscoelastic products used during ophthalmic viscosurgical cataract procedures including in part: If resistance is encountered during insertion, withdraw cannula and reassess the insertion conditions (i.e. insertion angle, incision size, etc.) before proceeding because forcing the cannula may cause corneal abrasion, iris trauma or descemet's membrane detachment.

   Z-3064-2026 · Root cause: Device Design · 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.

• MalfunctionJun 5, 2026Contamination

  IT WAS REPORTED THAT A PHYSICIAN OBSERVED WHITE DEBRIS BEING RELEASED FROM A NEW HEALON ENDOCOAT PRO DURING USE. THE PHYSICIAN WAS ABLE TO REMOVE THE DEBRIS FROM THE PATIENT¿S EYE. NO FURTHER INFORMATION WAS PROVIDED. THE PHYSICIAN REPORTED HAVING OBSERVED A SIMILAR OCCURRENCE PREVIOUSLY; HOWEVER, THAT EVENT WAS NOT REPORTED AT THE TIME. THIS MEDICAL DEVICE REPORT PERTAINS SPECIFICALLY TO THE INCIDENT REPORTED ON MAY 12, 2026. A SEPARATE REPORT WILL BE SUBMITTED FOR THE PRIOR SIMILAR EVENT EXPERIENCED BY THE PHYSICIAN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25411174 ↗