Constellation 8065751158Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00380657511587), received between May 21, 2021 and May 21, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Suction Failure” (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.

• MalfunctionMay 21, 2021Suction Failure; Suction Failure

  A PHYSICIAN REPORTED THAT THE PHACO TIP DID NOT ASPIRATE DURING PRE-PHACO; IT WAS LIKE THERE WAS A CLOG IN THE TIP. THE WOUND BECAME WHITE LIKE A BURN. AFTER THE OPERATION, A WHITE OBJECT WAS OBSERVED PASSING THROUGH THE ASPIRATION LINE. THE PHYSICIAN SUSPECTED THAT THE PREVIOUS FOREIGN MATERIAL MAY HAVE REMAINED IN THE TIP SINCE THE TIP WAS REUSED. THE PROCEDURE WAS COMPLETED. THE PATIENTS CURRENT OUTCOME IS UNKNOWN.

  Patient problems: Burn(s)

  MAUDE report 11861759 ↗