Constellation 8065750958Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00380657509584), received between Aug 13, 2021 and Feb 10, 2026 — classified as 3 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Break” (7 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. Jun 28, 2023Open, Classified

   Reports of patient injury during use in procedures due to potential for plastic debris from over-tightening with included plastic wrench.

   Z-2406-2023 · Root cause: Process control · FDA record ↗

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 10, 2026Break

  A CUSTOMER REPORTED THAT THE FRAGMENTATION TIP FRACTURED AND SHIFTED IN THE EYE OF THE PATIENT DURING SURGERY. THE PROCEDURE TYPE AND OTHER SURGERY DETAILS WERE UNKNOWN. THERE WAS NO INFORMATION ABOUT PATIENT IMPACT.

  Patient problems: Insufficient Information

  MAUDE report 24301737 ↗
• InjuryDec 10, 2025Break; Break

  A CUSTOMER REPORTED THAT THE METAL SHAFT OF THE FRAGMATOME CRACKED HALF WAY AND BROKE AWAY WHILE IN THE RIGHT EYE OF A FEMALE ELDERLY PATIENT DURING VITRECTOMY AND LENSECTOMY SURGERY. WHEN THE TIP BROKE OFF, IT WAS REQUIRED TO ENLARGE THE SCLERAL INCISION AND CREATE A CORNEAL INCISION AND A COUPLE OF AREAS THAT NEEDED TO BE LASERED WHERE THE TIP HAD LANDED. PATIENT HAD VITREOUS HEMORRHAGE AND HAD TO SUTURE CORNEAL INCISION ALONG WITH LASER AND A GAS BUBBLE. THEY HAD TO OPEN A NEW FRAGMATOME TIP AND REPLACED IT TO TAKE OUT REST OF LENS AND TIP HAD TO BE REMOVED FROM THE EYE. THE CURRENT PATIENT CONDITION WAS UNKNOWN.

  Patient problems: Vitreous Hemorrhage

  MAUDE report 23764907 ↗
• MalfunctionOct 16, 2024Break; Break

  A PHYSICIAN REPORTED THAT THE FRAGMENTATION TIP GOT BROKEN AND FELL INTO THE RETINA DURING SURGERY. SURGEON MANAGED AND REMOVED BROKEN TIP FROM RETINA. IT WAS UNKNOWN IF THE SURGERY WAS COMPLETED. THERE WAS NO INFORMATION ABOUT PROCEDURE TYPE AND PATIENT HARM.

  Patient problems: Insufficient Information

  MAUDE report 20459749 ↗
• MalfunctionNov 23, 2023Break; Break

  A NURSE REPORTED THAT THE FRAGMENTATION TIP WAS BROKE INSIDE PATIENT'S EYE DURING THE PROCEDURE. THE PROCEDURE TYPE WAS UNKNOWN. THE SURGERY WAS COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. BROKEN TIP REMOVED FROM THE PATIENT¿S EYE DURING THE SAME PROCEDURE. THERE WAS NO REPORT OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18197381 ↗
• InjurySep 29, 2023Failure to Cut; Adverse Event Without Identified Device or Use Problem; Failure to Cut; Adverse Event Without Identified Device or Use Problem

  A CUSTOMER REPORTED THAT FRAG WAS NOT ABLE TO BREAK UP THE CATARACT EFFICIENTLY DURING SURGERY. THE PATIENT EXPERIENCED THE EVENT NUCLEUS DROPPING POSTERIORLY. THE CURRENT OUTCOME OF THE PATIENT WAS UNKNOWN. THIS IS FIRST OF FOUR REPORTS FOR THIS ISSUE AND REPRESENTS THE OPHTHALMIC PROBE.

  Patient problems: Capsular Bag Tear

  MAUDE report 17841663 ↗
• MalfunctionNov 1, 2021Break; Break

  THE SAMPLE WAS NOT AVAILABLE FOR TESTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12729408 ↗
• MalfunctionOct 25, 2021Break; Break

  A PHYSICIAN REPORTED THE FRAGMENTATION TIPS NEEDLE BROKE AND SCATTERED IN THE PATIENT'S EYE DURING A SURGERY. HE TRIED TO ASPIRATE BUT COULD NOT GET THEM ALL. THERE WAS NO PATIENT HARM REPORTED. THE SAMPLE IS NOT AVAILABLE FOR RETURN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12693641 ↗
• InjuryAug 13, 2021Break; Break

  A NURSE REPORTED A FRAGMENTATION NEEDLE BROKE AND FELL TO THE BACK OF THE PATIENT¿S EYE DURING A PROCEDURE AND WHEN IT WAS RETRIEVED, IT CAUSED A RETINAL DETACHMENT.

  Patient problems: Retinal Detachment

  MAUDE report 12321172 ↗