CONSTELLATION® HYPERVIT® ENGAUGE® 8065830023Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00380658300234), received between Jul 31, 2023 and Jul 31, 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 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.

• InjuryJul 31, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A HEALTH PROFESSIONAL REPORTED A LITERATURE STUDY OF PROSPECTIVE CASE SERIES OF 55 EYES UNDERGOING PRIMARY PARS PLANA VITRECTOMY (PPV) FOR VARIOUS SURGICAL INDICATIONS. THE MAIN OUTCOME MEASURES WERE RATE OF ACHIEVING SURGICAL OBJECTIVES, OPERATIVE TIMES, NUMBER OF SURGICAL STEPS, USAGE OF ANCILLARY INSTRUMENTS, CORRECTED DISTANCE VISUAL ACUITY (CDVA), AND ADVERSE EVENTS. THE SURGICAL OBJECTIVES WERE ACHIEVED IN ALL EYES. THE ADVERSE EVENT RATE WAS 5% WITH NO VISUALLY THREATENING EVENTS. NONE OF THE EYES UNDERWENT SCLEROTOMY SUTURING. EIGHTY PERCENT OF PATIENTS REPORTED NO POSTOPERATIVE DISCOMFORT. ON POSTOPERATIVE DAY 1 ADVERSE EVENTS (AE) INCLUDED 2 CASES OF INCREASED IOP IN 2 CASES AND HYPOTONY IN ONE CASE (AE RATE OF 5.4%). THIS CASE PERTAINS TO A PATIENT WHO EXPERIENCED POSTOPERATIVE HYPOTONY. THIS EVENT WAS NOT SIGHT-THREATENING AND COMPLETELY RESOLVED WITH MEDICAL MANAGEMENT AND OBSERVATION. THIS IS ONE OF THREE REPORTS.

  Patient problems: Intraocular Pressure Decreased

  MAUDE report 17426242 ↗