Alcon, Intrepid 8065751510Recalls & reported problems

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 00380657515103), received between Jun 9, 2021 and Feb 27, 2026 — classified as 9 injuries, 20 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (6 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 29 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 27, 2026Material Twisted/Bent

  A PHYSICIAN REPORTED THAT BEFORE SURGERY AN OPHTHALMIC IRRIGATION AND ASPIRATION TIP WAS FOUND BENT. PROCEDURE DETAILS AND PATIENT IMPACT WERE NOT REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24468301 ↗
• InjuryNov 14, 2025Obstruction of Flow; Sharp Edges; Obstruction of Flow; Sharp Edges

  A CUSTOMER REPORTED THAT DURING CATARACT SURGERY WITH DISPOSABLE IRRIGATION AND ASPIRATION TIP (I/A TIP) CUSTOMER FELT STUCK AT THE TIME OF IRRIGATION AND ASPIRATION. CUSTOMER THOUGHT THERE WAS BURR IN THE TIP OF THE POLYMER IA (PORT PART). THE PATIENT EXPERIENCED CAPSULE RUPTURE. ANTERIOR VITRECTOMY SURGERY WAS PERFORMED, AND THE SURGERY WAS COMPLETED. THE CURRENT CONDITION OF THE PATIENT WAS UNKNOWN.

  Patient problems: Capsular Bag Tear

  MAUDE report 23554308 ↗
• MalfunctionOct 21, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  A PHYSICIAN REPORTED THAT BEFORE CATARACT SURGERY, AN OPHTHALMIC IRRIGATION AND ASPIRATION (IA) TIP CAME OFF FROM THE SLEEVE WHEN THE IA TIP WAS CONNECTED TO THE HANDPIECE. THE SURGERY WAS PERFORMED AND COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE ON THE SAME DAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23348803 ↗
• InjuryJul 14, 2025Sharp Edges; Sharp Edges

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING CATARACT SURGERY, A BURR WAS OBSERVED ON THE OPHTHALMIC IRRIGATION/ASPIRATION TIP DURING POSTERIOR CHAMBER POLISHING, AND THE PATIENT EXPERIENCED A POSTERIOR CAPSULE RUPTURE. THE SURGERY WAS COMPLETED ON THE SAME DAY AFTER THE PRODUCT WAS REPLACED. THE CURRENT CONDITION OF PATIENT IS RESOLVED.

  Patient problems: Capsular Bag Tear

  MAUDE report 22492608 ↗
• MalfunctionJun 23, 2025Break; Break

  A HEALTHCARE PROFESSIONAL REPORTED THAT, AFTER CATARACT SURGERY, AN OPHTHALMIC IRRIGATION OR ASPIRATION TIP HAD BROKEN OFF INSIDE THE HANDPIECE. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22305544 ↗
• MalfunctionMay 27, 2025Suction Failure; Suction Failure

  A PHYSICIAN REPORTED THAT DURING CATARACT SURGERY, AN OPHTHALMIC IRRIGATION AND ASPIRATION TIP BECAME UNUSABLE AND EXHIBIT ASPIRATION FAILURE. THE SURGERY WAS COMPLETED ON THE SAME DAY AFTER REPLACING THE PRODUCT WITH A NEW ONE. NO PATIENT HARM HAS BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22087661 ↗
• MalfunctionMay 13, 2025Material Twisted/Bent; Material Twisted/Bent

  A PHYSICIAN REPORTED THAT AN OPHTHALMIC IRRIGATION-ASPIRATION TIP WAS FOUND TO BE BENT BEFORE CATARACT SURGERY. THE SURGERY WAS COMPLETED WITH ALTERNATIVE PRODUCT. NO IMPACT ON PATIENT WAS REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 22008713 ↗
• MalfunctionMar 7, 2025Material Twisted/Bent; Material Twisted/Bent

  A CUSTOMER REPORTED THAT BEFORE CATARACT SURGERY TWO OPHTHALMIC IRRIGATION AND ASPIRATION TIPS FROM DIFFERENT LOT WERE FOUND BENT. THE SURGERY WAS COMPLETED ON THE SAME DAY WITH ALTERNATIVE TIP AND THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21545389 ↗
• MalfunctionMar 7, 2025Material Twisted/Bent; Material Twisted/Bent

  A CUSTOMER REPORTED THAT BEFORE CATARACT SURGERY TWO OPHTHALMIC IRRIGATION AND ASPIRATION TIPS FROM DIFFERENT LOT WERE FOUND BENT. THE SURGERY WAS COMPLETED ON THE SAME DAY WITH ALTERNATIVE TIP AND THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21545387 ↗
• MalfunctionFeb 19, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  A PHYSICIAN REPORTED THAT AN OPHTHALMIC TIP WAS DETACHED WHEN ATTEMPTING TO ATTACH WITH SLEEVE. SURGERY WAS COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. PROCEDURE DETAILS AND PATIENT IMPACT HAVE NOT BEEN PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE RECEIVED TILL DATE. ADDITIONAL INFORMATION RECEIVED THAT EVENT WHEN OPENING PACKAGE FOR CATARACT SURGERY. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21408728 ↗
• MalfunctionFeb 18, 2025Obstruction of Flow; Suction Failure; Obstruction of Flow; Suction Failure

  A PHYSICIAN REPORTED THAT DURING CATARACT SURGERY ASPIRATION FAILURE OCCURRED DUE TO OBSTRUCTION IN AN OPHTHALMIC IRRIGATION AND ASPIRATION TIP. THE SURGERY WAS COMPLETED WITH ALTERNATE TIP ON THE SAME DAY AND THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21404348 ↗
• MalfunctionJan 13, 2025Suction Failure; Suction Failure

  A PHYSICIAN REPORTED THAT DURING CATARACT SURGERY, AN OPHTHALMIC IRRIGATION/ASPIRATION TIP HAD ASPIRATION FAILURE DURING IRRIGATION/ASPIRATION. WHEN CONNECTED, TIP BECAME LOOSE AND TIP WAS DAMAGED AT THE BASE. THE SURGERY WAS COMPLETED ON THE SAME DAY WITH ALTERNATIVE PRODUCT. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21136373 ↗
• MalfunctionSep 25, 2024Break; Break

  A PHYSICIAN REPORTED THAT AN IRRIGATION AND ASPIRATION TIP WAS FOUND BROKEN BEFORE A CATARACT SURGERY. THE SURGERY WAS COMPLETED BY REPLACING THE TIP. NO PATIENT IMPACT WAS REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 20299386 ↗
• MalfunctionAug 23, 2024Suction Failure; Suction Failure

  A PHYSICIAN REPORTED THAT DURING IRRIGATION AND ASPIRATION STEP OF SURGERY AN OPHTHALMIC SURGICAL TIP ASPIRATION FAILURE OCCURRED. THE SURGERY WAS COMPLETED ON THE SAME DAY AFTER REPLACING THE PRODUCT WITH ANOTHER TIP. THE TYPE OF PROCEDURE WAS NOT REPORTED. NO PATIENT IMPACT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20057320 ↗
• MalfunctionAug 19, 2024Break; Break

  A PHYSICIAN REPORTED THAT BEFORE CATARACT SURGERY AN OPHTHALMIC SURGICAL TIP ATTACHED TO A HAND PIECE WAS TORN OFF FROM ITS ROOT. IT WAS ALSO REPORTED THAT, THE SCREW PART OF THE ROOT KEPT ATTACHED TO THE HAND PIECE AND AN UPPER PART FROM THERE WAS TORN OFF. THE SURGERY WAS COMPLETED ON THE SAME DAY AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THE PATIENT IMPACT WAS NOT REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 19999926 ↗
• MalfunctionAug 9, 2024Material Twisted/Bent; Material Twisted/Bent

  A PHYSICIAN REPORTED THAT DURING CATARACT VITRECTOMY COMBINATION SURGERY, AN OPHTHALMIC TIP WAS BENT. THE CONDITION WAS NOTICED BEFORE INSERTION INTO THE PATIENT'S EYE AND WAS REPLACED. SURGERY WAS COMPLETED ON THE SAME DAY WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19948250 ↗
• MalfunctionJul 16, 2024Break; Break

  A PHYSICIAN REPORTED THAT BEFORE CATARACT SURGERY AN OPHTHALMIC TIP WAS FOUND BROKEN. THE PRODUCT WAS REPLACED WITH A NEW ONE, AND THE SURGERY WAS COMPLETED. PATIENT IMPACT WAS NOT REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 19750152 ↗
• MalfunctionMar 4, 2024Material Twisted/Bent; Material Twisted/Bent

  A PHYSICIAN REPORTED THAT AN OPHTHALMIC IRRIGATION AND ASPIRATION TIP WAS FOUND BENT BEFORE SURGERY. THE SURGERY WAS COMPLETED ON THE SAME DAY WITH AN ALTERNATIVE TIP. PROCEDURE DETAILS AND PATIENT HARM WAS NOT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18827302 ↗
• MalfunctionFeb 29, 2024Complete Blockage; Complete Blockage

  A PHYSICIAN REPORTED THAT ASPIRATION FAILURE OF THE FLUIDIC MANAGEMENT SYSTEM OCCURRED DURING THE SIMULTANEOUS CATARACT AND GLAUCOMA SURGERY. CUSTOMER SUSPECTED THAT IRRIGATION ASPIRATION TIP OR HANDPIECE WAS CLOGGED, THE SURGERY WAS COMPLETED ON THE SAME DAY AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WAS NO REPORT OF PATIENT HARM.

  Patient problems: Insufficient Information

  MAUDE report 18805690 ↗
• MalfunctionJan 22, 2024Inability to Irrigate; Obstruction of Flow; Inability to Irrigate; Obstruction of Flow

  A PHYSICIAN REPORTED THAT AN OPHTHALMIC TIP HAS IRRIGATION FAILURE OCCURRED AND CLOGGED BEFORE SURGERY. WHEN CONNECTED TO IRRIGATION/ASPIRATION AND TURNED ON IRRIGATION, NO WATER CAME OUT. THE SURGEON FLUSHED WITH OPE-GUARD AND WATER CAME OUT, BUT WHEN CONNECTED IT AGAIN AND TRIED TO USE IT, IT WAS CLOGGED. 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 18551005 ↗
• InjuryNov 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NURSE REPORTED THAT DURING CATARACT SURGERIES, AN OPHTHALMIC CURVED TIP WAS UTILIZED, RESULTING IN PATIENTS EXPERIENCING CORNEAL BURNS AND CORNEAL EDEMA WITH THE RISK OF NON-HEALING. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Corneal Edema

  MAUDE report 18083080 ↗
• InjuryOct 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED INDICATING THAT PATIENT DID NOT EXPERIENCED CORNEAL BURN. NUMBER OF PATIENTS INVOLVED IS 15.

  Patient problems: Corneal Edema; Eye Burn

  MAUDE report 18011350 ↗
• 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 13867697 ↗
• 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 CARTRIDGE, 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 13867623 ↗
• 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 IRRIGATION/ASPIRATION TIP INVOLVED IN THIS EVENT.

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

  MAUDE report 13867401 ↗