CENTURION® INTREPID® 8065753134Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00380657531349), received between Mar 29, 2022 and Mar 2, 2026 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (1 report).

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-2407-2023 · Root cause: Process control · FDA record ↗

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 2, 2026Suction Problem

  A NURSE REPORTED THAT ASPIRATION WAS NOT WORKING DURING CATARACT SURGERY (WITH INTRAOCULAR LENSES IMPLANT). THE SURGERY WAS COMPLETED, BUT IT WAS UNKNOWN HOW IT WAS COMPLETED. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24480665 ↗
• MalfunctionApr 22, 2025Material Twisted/Bent; Material Twisted/Bent

  A CUSTOMER REPORTED THAT THE PHACOEMULSIFICATION TIP WAS DAMAGED DURING CATARACT SURGERY (WITHOUT INTRAOCULAR LENS IMPLANTATION). THE SURGERY WAS COMPLETED ON THE SAME DAY AFTER REPLACING WITH A NEW KIT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21879941 ↗
• InjuryOct 29, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PHYSICIAN REPORTED THAT DURING CATARACT SURGERY, A PATIENT EXPERIENCED CORNEAL BURN AND CORNEAL OPACITY. CORNEAL BURN WAS SUCCESSFULLY SEALED WITHOUT A SUTURE. OUTCOME OF THE PATIENT WAS UNKNOWN.

  Patient problems: Corneal Clouding/Hazing; Eye Burn

  MAUDE report 20556170 ↗
• MalfunctionMar 29, 2022Particulates; Particulates

  A PHYSICIAN REPORTED METALLIC FOREIGN BODY IN PATIENT IRIS AT ONE-MONTH POST-PROCEDURE. THERE WAS NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION PROVIDED THAT THE FOREIGN MATERIAL IS STILL INSITU AND NO ADDITIONAL INTERVENTION HAS BEEN REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13936742 ↗