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Constellation 8065751514Recalls & reported problems

Alcon Laboratories, Inc. · Constellation Vision System Basic Vitrectomy Pak · Class 2

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00380657515141), received between May 19, 2023 and May 19, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Fluid/Blood Leak” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Fluid/Blood Leak1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

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

  • MalfunctionMay 19, 2023Fluid/Blood Leak; Fluid/Blood Leak

    A CUSTOMER REPORTED THAT SALINE SOLUTION WAS LOST THROUGH THE CASSETTE WHEN PLACED THE CASSETTE TO MAKE THE PRIME. THE VITRECTOMY SURGERY WAS COMPLETED AFTER REPLACING THE PRODUCT. THERE WAS NO PATIENT HARM.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16962037 ↗

Other Instrument, vitreous aspiration and cutting, ac-powered devices

All Instrument, vitreous aspiration and cutting, ac-powered devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.