HEALON PRO 10240011Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05050474636972), received between Apr 22, 2019 and Apr 22, 2019 — classified as 1 injury.

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

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

• InjuryApr 22, 2019Separation Problem; Separation Problem

  IT WAS REPORTED THAT WHEN THE SURGEON ENGAGED, PULLED OUT THE HEALON PLUNGER DURING RETRACTION, THE HEALON CANNULA SHOT OFF INTO THE PATIENT'S EYE AND THE FORCE LED TO TEAR IN THE CAPSULE. REPORTEDLY, THIS ALTERED THE SURGICAL PLAN OF RELAXING CUT 90° AWAY, IOL SULCUS OPTIC CAPSULE HEALON TO MAINTAIN DURING CHANGES AND MIOSTAT WAS USED. IT WAS INDICATED THAT THE SURGERY COMPLETED SUCCESSFULLY AND THAT THE PATIENT OUTCOME IS WITHIN THE NORMAL LIMITS. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Capsular Bag Tear

  MAUDE report 8537686 ↗