Constellation 8065750918Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00380657509188), received between Mar 25, 2022 and Jan 14, 2026 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Disconnection” (4 reports).

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. Aug 5, 2025Open, Classified

   Due to incomplete seals in the pouch which provide the sterile barrier.

   Z-0305-2026 · Root cause: Process control · FDA record ↗

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 14, 2026Infusion or Flow Problem

  A PHYSICIAN REPORTED THAT THE TUBE WAS NOT DELIVERING WATER DURING VITRECTOMY SURGERY. THE PRODUCT WAS PROMPTLY REPLACED WITH A NEW ONE, AND THE SURGERY WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24065382 ↗
• MalfunctionJan 9, 2026Infusion or Flow Problem

  A PHYSICIAN REPORTED THAT IT WAS DISCOVERED THAT THE TUBE WAS NOT DELIVERING WATER DURING VITRECTOMY SURGERY. THE PRODUCT WAS PROMPTLY REPLACED WITH A NEW ONE, AND THE SURGERY WAS COMPLETED. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24017810 ↗
• MalfunctionMay 12, 2025Complete Blockage; Complete Blockage

  A NON-HEALTH CARE PROFESSIONAL REPORTED THAT TUBING OBSTRUCTION IMPEDIMENT BEFORE INTRAOCULAR LENS IMPLANTATION SURGERY. PROCEDURE COMPLETION DETAILS WERE UNKNOWN. THERE WAS NO PATIENT IMPACT REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 22000191 ↗
• MalfunctionMar 19, 2025Loose or Intermittent Connection; Loose or Intermittent Connection

  A NURSE REPORTED THAT A PHACO TIP COULD NOT BE TIGHTLY CONNECTED TO HANDPIECE BEFORE VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED ON THE SAME DAY AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21640382 ↗
• MalfunctionAug 26, 2024Infusion or Flow Problem; Infusion or Flow Problem

  A NURSE REPORTED THAT THE TUBE WAS BLOCKED AND COULD NOT BE ASPIRATED NORMALLY DURING CATARACT/VITRECTOMY COMBINATION SURGERY. THE SURGERY WAS COMPLETED AFTER REPLACEMENT OF THE IRRIGATION/ASPIRATION TUBING SET. THERE WERE NO OTHER ABNORMALITIES. THE PATIENT RETURNED TO THE WARD SMOOTHLY AFTER COMPLETING THE SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20064491 ↗
• MalfunctionMay 22, 2023Loose or Intermittent Connection; Loose or Intermittent Connection

  THE FILE HAS BEEN DOWNGRADED TO NON REPORTABLE EVENT CONNECTOR ISSUE AFTER THE INTERNAL REVIEW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16974368 ↗
• MalfunctionMay 9, 2023Disconnection; Disconnection

  A PHYSICIAN REPORTED THAT THE TUBE WAS NOT CONNECTED WITH THE HANDPIECE TIGHTLY DURING THE VITRECTOMY SURGERY. THE PRODUCT WAS REPLACED AND THE SURGERY WAS COMPLETED. THERE WAS NO PATIENT HARM. AS A RESULT OF AN INTERNAL REVIEW OF THE FILE, IT WAS DETERMINED THAT THE INFORMATION PROVIDED FOR THIS EVENT TUBE COULD NOT CONNECT WITH THE HANDPIECE TIGHTLY DUE TO CONNECTOR LOOSE ISSUE DURING SURGERY, DOES NOT REPRESENT A REPORTABLE DEVICE MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16894231 ↗
• MalfunctionMar 2, 2023Disconnection; Disconnection

  A NURSE REPORTED THAT THE IRRIGATION ASPIRATION (IA) TUBE WAS NOT TIGHTLY CONNECTED WITH THE HANDPIECE AND WAS EASILY FALLING OFF DURING THE PHACOEMULSIFICATION (PHACO) PHASE OF THE CATARACT SURGERY. THE TUBE WAS REPLACED WITH A NEW TUBE WHICH WORKED NORMALLY, AND THE SURGERY WAS COMPLETED. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16467587 ↗
• MalfunctionJun 8, 2022Fluid/Blood Leak; Detachment of Device or Device Component; Fluid/Blood Leak; Detachment of Device or Device Component

  A PHYSICIAN REPORTED THE TUBE CONNECTING THE HANDPIECE WAS NOT TIGHT, RESULTING IN WATER LEAKAGE DURING A CATARACT SURGERY. THE PRODUCT WAS REPLACED AND THE SURGERY WAS COMPLETED. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14631846 ↗
• MalfunctionMay 26, 2022Disconnection; Fluid/Blood Leak; Disconnection; Fluid/Blood Leak

  A PHYSICIAN REPORTED TUBING SET TO CONNECT THE HANDPIECE, THE CONNECTION WAS NOT TIGHT, LOOSEN AND CAUSED WATER LEAKAGE DURING CATARACT PROCEDURE. THE PROCEDURE WAS COMPLETED AFTER THE THIRD REPLACEMENT. THERE WAS NO PATIENT HARM. THIS IS ONE OF TWO REPORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14513712 ↗
• MalfunctionMay 26, 2022Disconnection; Fluid/Blood Leak; Disconnection; Fluid/Blood Leak

  A PHYSICIAN REPORTED TUBING SET TO CONNECT THE HANDPIECE, THE CONNECTION WAS NOT TIGHT, LOOSEN AND CAUSED WATER LEAKAGE DURING CATARACT PROCEDURE. THE PROCEDURE WAS COMPLETED AFTER THE THIRD REPLACEMENT. THERE WAS NO PATIENT HARM. THIS IS TWO OF TWO REPORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14513307 ↗
• MalfunctionMar 25, 2022Air/Gas in Device; Air/Gas in Device

  A NURSE REPORTED AIR BUBBLES IN IRRIGATION TUBING DURING A VITRECTOMY PROCEDURE. THE PROCEDURE WAS COMPLETED AFTER THE PRODUCT WAS REPLACED. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13899848 ↗