CONSTELLATION® ULTRAVIT® ENGAUGE® 8065751700Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00380657517008), received between Aug 17, 2018 and Sep 5, 2024 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Failure to Cut” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 5, 2024Failure to Cut; Failure to Cut

  A NURSE REPORTED THAT THE PROBE COULD NOT CUT DURING VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED AFTER REPLACING THE PROBE WITH ANOTHER ONE. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20143091 ↗
• InjuryAug 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IN LITERATURE STUDY ARTICLE, A NON-HEALTH PROFESSIONAL REPORTED THAT TO COMPARE THE EFFECTIVENESS AND SAFETY OF A 27-GAUGE (27G) BEVELED-TIP VITRECTOMY PROBE IN MICROINCISION VITRECTOMY SURGERY (MIVS) WITH A CONVENTIONAL 25-GAUGE (25G) VITRECTOMY PROBE FOR THE TREATMENT OF SERIOUS PROLIFERATIVE DIABETIC RETINOPATHY (PDR). FIFTY-TWO PATIENTS WHO WERE DEFINITIVELY DIAGNOSED WITH PDR AND REQUIRED VITRECTOMY TO REMOVE THE PROLIFERATIVE MEMBRANE. THE PRIMARY OUTCOME MEASURE WAS THE PRODUCTIVITY OF CUTTING THE MEMBRANE THROUGHOUT THE OPERATION. THE IMPORTANT SECONDARY OUTCOME MEASURES WERE THE NUMBER OF VITRECTOMY PROBES (VPS) SWITCHED TO MICRO FORCEPS, INTRAOPERATIVE AND POSTOPERATIVE COMPLICATIONS, POSTOPERATIVE BEST-CORRECTED VISUAL ACUITY (BCVA) AND PREOPERATIVE INTRAOCULAR PRESSURE (IOP) OF PATIENTS DURING THE 6-MONTH FOLLOW-UP PERIOD. COMPARED WITH THE 25G FLAT-TIP VITRECTOMY PROBE, THE 27G BEVELED-TIP VITRECTOMY PROBE CONTRIBUTES TO REMOVING THE PROLIFERATIVE MEMBRANE MORE EFFICIENTLY AND EASILY. IT ALSO REDUCED THE OCCURRENCE OF INTRAOPERATIVE HEMORRHAGES AND THUS AVOIDED EXCESSIVE ELECTROCOAGULATION. IN TERMS OF TREATMENT OUTCOME, THE ADVANCED BEVEL-TIP VITRECTOMY PROBE IS AS EF

  Patient problems: Intraocular Pressure Decreased; Intraocular Pressure Increased; Vitreous Hemorrhage

  MAUDE report 17450547 ↗
• MalfunctionAug 17, 2018Self-Activation or Keying

  STAFF REPORTED THAT A CONSTELLATION 27+ ULTRAVIT HANDPIECE WAS NOT WORKING PROPERLY. THE SURGEON NOTED THAT THE HANDPIECE WAS SUCTIONING WITHOUT THE FOOTPEDAL BEING DEPRESSED. A NEW HANDPIECE WAS USED TO COMPLETE THE PROCEDURE AS PLANNED AND NO HARM CAME TO THE PATIENT. THE HANDPIECE WAS SAVED FOR CLINICAL ENGINEERING AND WILL BE RETURNED TO THE MANUFACTURER FOR FAILURE ANALYSIS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7792625 ↗