Constellation, Ultravit, 27+, TotalPlus, EdgePlus 8065752059Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00380657520596), received between Oct 28, 2021 and Aug 22, 2024 — classified as 2 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Failure to Cut” (5 reports).

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

• MalfunctionAug 22, 2024Dull, Blunt; Dull, Blunt

  A PHYSICIAN REPORTED THAT TROCAR BLADE WAS DIFFICULT FOR THE PRODUCT TO BE SPIKED DURING SURGERY. THE PROCEDURE TYPE WAS UNKNOWN. THE SURGERY WAS COMPLETED AFTER REPLACING THE PRODUCT WITH NEW ONE. THE PATIENT HARM WAS NOT REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 20029863 ↗
• MalfunctionJul 20, 2024Break; Break

  A PHYSICIAN REPORTED THAT THE VITRECTOMY PROBE HEAD BROKEN IN EYE, AND IT HAS BEEN REMOVED DURING VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED AFTER REPLACING THE PRODUCT WITH NEW ONE. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19786938 ↗
• MalfunctionMay 15, 2024Failure to Cut; Failure to Cut

  A NURSE REPORTED THAT POOR CUTTING WAS OBSERVED BEFORE VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19327666 ↗
• MalfunctionFeb 22, 2024Failure to Cut; Failure to Cut

  A PHYSICIAN REPORTED THAT CUTTING OF PROBE COULD NOT BEEN PERFORMED DURING CATARACT AND VITRECTOMY COMBINATION SURGERY. THE CONDITION OF ASPIRATION AND ACTUATION WAS UNKNOWN. THE SURGERY WAS SUCCESSFULLY COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18756643 ↗
• MalfunctionAug 28, 2023Failure to Cut; Failure to Cut

  A PHYSICIAN REPORTED THAT ACTUATION FAILURE OF THE PROBE OCCURRED, AND THE CUTTER COULD NOT BE OPENED AND CLOSED AT ALL DURING THE CATARACT AND VITRECTOMY COMBINATION SURGERY. THE CONDITION OF ASPIRATION IS UNKNOWN. THE SURGERY WAS COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER PRODUCT. THERE WAS NO REPORT OF PATIENT HARM.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17632024 ↗
• MalfunctionDec 16, 2022Material Twisted/Bent; Material Twisted/Bent

  A PHYSICIAN REPORTED TIP OF THE PRODUCT WAS FOUND TO BE BENT DURING A CATARACT VITRECTOMY COMBINATION PROCEDURE. THE PRODUCT WAS REPLACED AND THE PROCEDURE WAS COMPLETED. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15996406 ↗
• MalfunctionOct 21, 2022Failure to Cut; Failure to Cut

  A PHYSICIAN REPORTED THE CUTTER PROBE COULD NOT BE USED DURING VITRECTOMY SURGERY. THERE WAS A CUTTING FAILURE HOWEVER NO ASPIRATION ERROR REPORTED. THE SURGERY WAS COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15650197 ↗
• MalfunctionMay 6, 2022Fluid/Blood Leak; Failure to Prime; Fluid/Blood Leak; Failure to Prime

  A PHYSICIAN REPORTED CASSETTE LEAK AND COULD NOT PASS THE TEST BEFORE A VITRECTOMY SURGERY. THERE WAS NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION RECEIVED FROM THE COMPANY REPRESENTATIVE WHO STATED THAT THE PRODUCT WAS REPLACED AND THE PROCEDURE WAS COMPLETE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14305143 ↗
• InjuryApr 5, 2022Fluid/Blood Leak; Fluid/Blood Leak

  A PHYSICIAN REPORTED WHILE INDENTING THE GLOBE A FRESH RETINAL FORAMEN WAS FOUND. THE FORAMINA WERE TREATED WITH LASER THE EYE WAS SUPPLIED WITH GAS AND PATIENT HAD TO CAMP. NO HOSPITALIZATION WAS REQUIRED. THE POSTOPERATIVE COURSE WAS UNCOMPLICATED. ADDITIONAL INFORMATION RECEIVED FROM THE COMPANY REPRESENTATIVE INDICATING DURING THE SURGERY ALL THE 27G AND 25G TROCARS WERE SPONTANEOUSLY LEAKING IMMEDIATELY AFTER INSERTION LEAKED OUT OF THE VALVES. THERE WERE MULTIPLE PRODUCTS REPORTED FROM THE SITE AND IT IS STILL UNKNOWN IF THIS ACTUAL PRODUCT IS ASSOCIATED WITH THE COMPLAINT. THIS REPORT IS OF 27G.

  Patient problems: Retinal Injury

  MAUDE report 14014490 ↗
• InjuryApr 5, 2022Fluid/Blood Leak; Fluid/Blood Leak

  A PHYSICIAN REPORTED WHILE INDENTING THE GLOBE A FRESH RETINAL FORAMEN WAS FOUND. THE FORAMINA WERE TREATED WITH LASER THE EYE WAS SUPPLIED WITH GAS AND PATIENT HAD TO CAMP. NO HOSPITALIZATION WAS REQUIRED. THE POSTOPERATIVE COURSE WAS UNCOMPLICATED. ADDITIONAL INFORMATION RECEIVED FROM THE COMPANY REPRESENTATIVE INDICATING DURING THE SURGERY ALL THE 27G AND 25G TROCARS WERE SPONTANEOUSLY LEAKING IMMEDIATELY AFTER INSERTION LEAKED OUT OF THE VALVES. THIS REPORT IS FOR 27G TROCAR.

  Patient problems: Retinal Injury

  MAUDE report 14014287 ↗
• MalfunctionJan 13, 2022Failure to Cut; Failure to Cut

  A PHYSICIAN REPORTED THE CUTTER CEASED TO ACTUATE AND ASPIRATION WAS WORKING NORMALLY DURING A 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 13247199 ↗
• MalfunctionOct 28, 2021Fluid/Blood Leak; Fluid/Blood Leak

  AFTER A REVIEW OF THE CURRENT INFORMATION PROVIDED, IT WAS CLARIFIED THAT BOTH THE 25 GAUGE AND 27 GAUGE VALVED TROCARS HAVE BEEN SPONTANEOUSLY LEAKING FOR THE PAST FEW MONTHS. THE IMPACT TO THE PATIENTS HAS NOT BEEN REPORTED. THIS ONE REPRESENTS THE 27 GAUGE VALVED TROCARS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12712942 ↗