INTREPID® 8065751012Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00380657510122), received between May 7, 2022 and Aug 7, 2026 — classified as 4 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Break” (3 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. How this data works · Data updated Oct 13, 2026.

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.

• MalfunctionAug 7, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50174982 ↗
• InjuryNov 18, 2024Break; Break

  A PHYSICIAN REPORTED THAT DURING SURGERY, PATIENT EXPERIENCED POSTERIOR CAPSULE RUPTURE WHILE REMOVING CORTEX WITH THE IRRIGATION ASPIRATION HANDPIECE. IT WAS NOTED THAT THE SUCTION PORT OF THE IRRIGATION ASPIRATION TIP WAS DAMAGED, LIKELY DUE TO A BURR ON THE TIP. SURGERY WAS COMPLETED ON THE SAME DAY WITH AN ALTERNATIVE TIP AND BY CHANGING THE TYPE OF INTRAOCULAR LENS (IOL) FROM A SINGLE-PIECE IOL TO A THREE-PIECE IOL, WHICH WAS SCHEDULED FOR INSERTION.

  Patient problems: Rupture

  MAUDE report 20706617 ↗
• InjuryMar 13, 2024Scratched Material; Scratched Material

  A PHYSICIAN REPORTED THAT THE OPHTHALMIC TIPS HAVE SCRATCHES OR BURR AND THE PATIENTS EXPERIENCED RUPTURE. THE SURGERY WAS COMPLETED WITHOUT PRODUCT REPLACEMENT. THE PROCEDURE TYPE IS UNKNOWN.

  Patient problems: Capsular Bag Tear

  MAUDE report 18893150 ↗
• InjuryMar 8, 2024Scratched Material; Scratched Material

  A PHYSICIAN REPORTED THAT THE SMALL HOLE WAS MADE WHEN THE POSTERIOR CAPSULE WAS TOUCHED WITH OPHTHALMIC IRRIGATION ASPIRATION (IA) TIP DURING CORTICAL ASPIRATION. THE OPHTHALMIC TIP WAS WITH SCRATCHES OR BURR. THE SURGERY WAS COMPLETED WITHOUT PRODUCT REPLACEMENT. THE PROCEDURE TYPE IS UNKNOWN. THE PATIENT HAD ADDITIONAL ANTERIOR VITRECTOMY SURGERY.

  Patient problems: Capsular Bag Tear

  MAUDE report 18864432 ↗
• InjuryMar 6, 2024Device Handling Problem; Device Handling Problem

  A PHYSICIAN REPORTED AFTER IMPLANTATION OF THE INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, THE POSTOPERATIVE VISUAL ACUITY HAD DECREASED AFTER SURGERY AND. THERE WAS A FOLD BEHIND THE INTRAOCULAR LENS (POSTERIOR CAPSULE), BUT THE VITREOUS (ESPECIALLY THE ANTERIOR VITREOUS) SEEMS TO BE CLOUDING ALONG IT. THERE ALSO APPEARED TO BE A BIT OF CORNEAL ENDOTHELIITIS. SURGEON ALSO CONSIDERED THAT AS ANOTHER FACTOR OTHER THAN IOL, AN OPHTHALMIC REUSABLE IRRIGATION ASPIRATION TIP MIGHT NOT HAVE BEEN CLEANED AND STERILIZED SUFFICIENTLY AFTER USE. THERE ARE FOUR MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS COMPLAINT. THIS REPORT IS 3 OF 4.

  Patient problems: Blurred Vision; Inflammation; Vitritis

  MAUDE report 18844573 ↗
• MalfunctionMar 1, 2024Obstruction of Flow; Obstruction of Flow

  A CUSTOMER REPORTED THAT DURING SURGERY, THE TIP WAS CLOGGED WHEN USING IA. THE SURGERY WAS COMPLETED WITH ANOTHER PRODUCT. THERE'S NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18815115 ↗
• MalfunctionJan 29, 2024Break; Break

  A PHYSICIAN REPORTED THAT OPHTHALMIC IRRIGATION/ASPIRATION TIP BROKE OFF AT THE ROOT WHICH WAS ATTACHED WITH A WRENCH BEFORE SURGERY. THE SURGERY WAS PERFORMED AND COMPLETED ON THE SAME DAY AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THE PROCEDURE TYPE AND PATIENT IMPACT WERE NOT REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 18594144 ↗
• MalfunctionMay 7, 2022Particulates; Particulates

  A GOVERNMENT AGENCY REPORTED THAT A SILVERY WHITE FOREIGN BODY WAS FOUND ATTACHED TO THE IRIS OF THE NASAL SIDE OF THE RIGHT EYE AFTER A CATARACT PROCEDURE. ADDITIONAL INFORMATION RECEIVED INDICATING THAT THE FOREIGN BODY WAS NOT TOTALLY REMOVED FROM THE EYE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14315182 ↗