CONSTELLATION® ULTRAVIT® ENGAUGE® 8065750950Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00380657509508), received between Aug 3, 2023 and Aug 3, 2023 — classified as 1 injury.

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

• 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 17450596 ↗