CENTURION, Interpid 8065752900Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00380657529001), received between Apr 9, 2021 and Nov 27, 2025 — classified as 7 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Particulates” (2 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.

• MalfunctionNov 27, 2025Product Quality Problem; Product Quality Problem

  A PHYSICIAN REPORTED THAT THE SLEEVE BECAME WIDE AND MADE FOLD WHILE ENTERING IN FROM THE INCISION DURING CATARACT SURGERY WITH INTRAOCULAR LENS IMPLANTATION. THE PROCEDURE WAS COMPLETED BY REPLACING THE PACK WITH NEW ONE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23664070 ↗
• MalfunctionAug 1, 2025Product Quality Problem; Product Quality Problem

  A PHYSICIAN REPORTED SLEEVES WERE DEFECTIVE AND INCLUDED BOTH A SLEEVE WITH NO HOLES AND A SLEEVE WITH MULTIPLE HOLES DURING CATARACT SURGERY (WITH INTRAOCULAR LENS IMPLANT). THE SURGERY WAS PERFORMED AND COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WAS NO REPORT OF PATIENT IMPACT.

  Patient problems: Insufficient Information

  MAUDE report 22684606 ↗
• MalfunctionMar 25, 2025Material Puncture/Hole; Material Puncture/Hole

  A PHYSICIAN REPORTED THAT THERE WAS A HOLE IN SLEEVE AND LEAKAGE OCCURRED DURING CATARACT/VITRECTOMY COMBINATION SURGERY. THE SURGERY WAS COMPLETED ON THE SAME DAY AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21687504 ↗
• InjuryJan 3, 2025Particulates; Particulates

  A PHYSICIAN REPORTED THAT A THREAD-LIKE FIBER WAS FOUND INSIDE THE PATIENT'S EYE AFTER CATARACT SURGERY WITH INTRAOCULAR LENS IMPLANTATION. THERE WAS NO INFORMATION ABOUT PATIENT IMPACT. ADDITIONAL INFORMATION WAS RECEIVED THAT THE FOREIGN MATERIAL WAS REMOVED FROM THE PATIENT'S EYE BY PERFORMING ADDITIONAL SURGERY. THE CURRENT CONDITION OF THE PATIENT WAS UNKNOWN. ADDITIONAL INFORMATION WAS RECEIVED AND CONFIRMED THAT THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21074823 ↗
• MalfunctionApr 20, 2022Material Split, Cut or Torn; Material Split, Cut or Torn

  A PHYSICIAN REPORTED THE SLEEVE WAS FOUND TORN DURING A CATARACT PROCEDURE. THE PROCEDURE WAS COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WAS NO PATIENT HARM. THE SAMPLE WAS NOT AVAILABLE FOR RETURN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14159220 ↗
• InjuryApr 5, 2022Particulates; Insufficient Flow or Under Infusion; Particulates; Insufficient Flow or Under Infusion

  A CUSTOMER REPORTED THE SURGEON NOTED WHITE FILAMENT WITHIN THE SHAFT OF THE PHACOEMULSIFICATION SLEEVE DURING QUADRANT REMOVAL IN CATARACT PROCEDURE. THE IRRIGATION FLOW WAS LOWER THAN NORMAL. THE PROCEDURE WAS COMPLETED AFTER THE PRODUCT WAS REPLACED. THERE WAS NO STRUCTURAL DAMAGE OCCURRED TO THE EYE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14014369 ↗
• InjuryMar 23, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PHYSICIAN REPORTED THAT AFTER A CATARACT SURGERY PATIENT EXPERIENCED INFLAMMATION (FIBRIN) AND ENDOPHTHALMITIS. PATIENT WAS GIVEN WITH AN ANTIBACTERIAL AGENT AND THE CONDITION WAS IMPROVING. IT WAS INFORMED THAT THE PATIENT WAS IN CONTACT WITH SURGICAL PROCEDURE PACKS, VISCOELASTICS, OPHTHALMIC PHACOEMULSIFICATION TIP, OPHTHALMIC PHACOEMULSIFICATION HANDPIECE AND IRRIGATION/ASPIRATION TIP. ADDITIONAL INFORMATION WAS RECEIVED CLARIFYING THE SURGEON CONFIRMED THE EVENT WAS TASS (TOXIC ANTERIOR SEGMENT SYNDROME).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Toxic Anterior Segment Syndrome (TASS); Uveitis

  MAUDE report 13867826 ↗
• InjuryMar 23, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PHYSICIAN REPORTED THAT AFTER A CATARACT SURGERY PATIENT EXPERIENCED INFLAMMATION (FIBRIN) AND ENDOPHTHALMITIS. PATIENT WAS GIVEN WITH AN ANTIBACTERIAL AGENT AND THE CONDITION WAS IMPROVING. IT WAS INFORMED THAT THE PATIENT WAS IN CONTACT WITH OPHTHALMIC CATRIDGE, SURGICAL PROCEDURE PACKS, VISCOELASTICS, OPHTHALMIC PHACOEMULSIFICATION TIP, OPHTHALMIC PHACOEMULSIFICATION HANDPIECE AND IRRIGATION/ASPIRATION TIP. ADDITIONAL INFORMATION WAS RECEIVED CLARIFYING THE SURGEON CONFIRMED THE EVENT WAS TASS (TOXIC ANTERIOR SEGMENT SYNDROME).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Toxic Anterior Segment Syndrome (TASS); Uveitis

  MAUDE report 13867641 ↗
• InjuryMar 23, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PHYSICIAN REPORTED THAT AFTER A CATARACT SURGERY PATIENT EXPERIENCED INFLAMMATION (FIBRIN) AND ENDOPHTHALMITIS. PATIENT WAS GIVEN WITH AN ANTIBACTERIAL AGENT AND THE CONDITION WAS IMPROVING. IT WAS INFORMED THAT THE PATIENT WAS IN CONTACT WITH OPHTHALMIC CATRIDGE, SURGICAL PROCEDURE PACKS, VISCOELASTICS, OPHTHALMIC PHACOEMULSIFICATION TIP, OPHTHALMIC PHACOEMULSIFICATION HANDPIECE AND IRRIGATION/ASPIRATION TIP. ADDITIONAL INFORMATION WAS RECEIVED CLARIFYING THE SURGEON CONFIRMED THE EVENT WAS TASS (TOXIC ANTERIOR SEGMENT SYNDROME).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Toxic Anterior Segment Syndrome (TASS); Uveitis

  MAUDE report 13867290 ↗
• InjuryMar 23, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PHYSICIAN REPORTED THAT AFTER A CATARACT SURGERY PATIENT EXPERIENCED INFLAMMATION (FIBRIN) AND ENDOPHTHALMITIS. PATIENT WAS GIVEN WITH AN ANTIBACTERIAL AGENT AND THE CONDITION WAS IMPROVING. IT WAS INFORMED THAT THE PATIENT WAS IN CONTACT WITH SURGICAL PROCEDURE PACKS, VISCOELASTICS, OPHTHALMIC PHACOEMULSIFICATION TIP, OPHTHALMIC PHACOEMULSIFICATION HANDPIECE AND IRRIGATION/ASPIRATION TIP. ADDITIONAL INFORMATION WAS RECEIVED CLARIFYING THE SURGEON CONFIRMED THE EVENT WAS TASS (TOXIC ANTERIOR SEGMENT SYNDROME). THIS REPORT REPRESENTS SURGICAL PROCEDURE PAK INVOLVED IN THIS EVENT.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Toxic Anterior Segment Syndrome (TASS); Uveitis

  MAUDE report 13867287 ↗
• InjuryMar 23, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PHYSICIAN REPORTED THAT AFTER A CATARACT SURGERY PATIENT EXPERIENCED INFLAMMATION (FIBRIN) AND ENDOPHTHALMITIS. PATIENT WAS GIVEN WITH AN ANTIBACTERIAL AGENT AND THE CONDITION WAS IMPROVING. IT WAS INFORMED THAT THE PATIENT WAS IN CONTACT WITH SURGICAL PROCEDURE PACKS, VISCOELASTICS, OPHTHALMIC PHACOEMULSIFICATION TIP, OPHTHALMIC PHACOEMULSIFICATION HANDPIECE AND IRRIGATION/ASPIRATION TIP. ADDITIONAL INFORMATION WAS RECEIVED CLARIFYING THE SURGEON CONFIRMED THE EVENT WAS TASS (TOXIC ANTERIOR SEGMENT SYNDROME). THIS REPORT REPRESENTS SURGICAL PROCEDURE PAK INVOLVED IN THIS EVENT.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Toxic Anterior Segment Syndrome (TASS); Uveitis

  MAUDE report 13867177 ↗
• MalfunctionApr 9, 2021Use of Device Problem; Use of Device Problem

  A CUSTOMER REPORTED THAT THE INFUSION SLEEVE WAS EASILY CUT AND WAS UNUSABLE DURING A PROCEDURE. THE PRODUCT WAS REPLACED AND PROCEDURE COMPLETED WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11643278 ↗