Alcon, Intrepid 8065751922Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 00380657519224), received between Jun 29, 2021 and Mar 18, 2026 — classified as 7 injuries, 13 malfunctions.

The most frequently reported specific device problem is “Suction Failure” (10 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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 18, 2026Suction Failure

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING A REFRACTIVE LENS EXCHANGE (RLE) SURGERY; WHILE REPLACING THE NATURAL LENS WITH AN ACRYLIC LENS IN THE LEFT EYE, BUBBLES WERE OBSERVED DURING CORTEX REMOVAL USING AN OPHTHALMIC IRRIGATION¿ASPIRATION HANDPIECE. THE SURGERY WAS COMPLETED THE SAME DAY USING AN ALTERNATIVE HANDPIECE, AND THERE WAS NO HARM TO THE PATIENT. THIS REPORT PERTAINS TO SEVEN OF SEVEN REPORTS FROM THE SAME FACILITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24632158 ↗
• MalfunctionMar 18, 2026Suction Failure

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING A REFRACTIVE LENS EXCHANGE (RLE) SURGERY; WHILE REPLACING THE NATURAL LENS WITH AN ACRYLIC LENS IN THE RIGHT EYE, BUBBLES WERE OBSERVED DURING CORTEX REMOVAL USING AN OPHTHALMIC IRRIGATION¿ASPIRATION HANDPIECE. THE SURGERY WAS COMPLETED THE SAME DAY USING AN ALTERNATIVE HANDPIECE, AND THERE WAS NO HARM TO THE PATIENT. THIS REPORT PERTAINS TO FIVE OF SEVEN REPORTS FROM THE SAME FACILITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24631311 ↗
• MalfunctionMar 18, 2026Suction Failure

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING A REFRACTIVE LENS EXCHANGE (RLE) SURGERY; WHILE REPLACING THE NATURAL LENS WITH AN ACRYLIC LENS IN THE RIGHT EYE, BUBBLES WERE OBSERVED DURING CORTEX REMOVAL USING AN OPHTHALMIC IRRIGATION¿ASPIRATION HANDPIECE. THE SURGERY WAS COMPLETED THE SAME DAY USING AN ALTERNATIVE HANDPIECE, AND THERE WAS NO HARM TO THE PATIENT. THIS REPORT PERTAINS TO SIX OF SEVEN REPORTS FROM THE SAME FACILITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24629256 ↗
• MalfunctionMar 18, 2026Suction Failure

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING A REFRACTIVE LENS EXCHANGE (RLE) SURGERY; WHILE REPLACING THE NATURAL LENS WITH AN ACRYLIC LENS IN THE RIGHT EYE, BUBBLES WERE OBSERVED DURING CORTEX REMOVAL USING AN OPHTHALMIC IRRIGATION¿ASPIRATION HANDPIECE. THE SURGERY WAS COMPLETED THE SAME DAY USING AN ALTERNATIVE HANDPIECE, AND THERE WAS NO HARM TO THE PATIENT. THIS REPORT PERTAINS TO THREE OF SEVEN REPORTS FROM THE SAME FACILITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24629247 ↗
• MalfunctionMar 18, 2026Suction Failure

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING A REFRACTIVE LENS EXCHANGE (RLE) SURGERY; WHILE REPLACING THE NATURAL LENS WITH AN ACRYLIC LENS IN THE RIGHT EYE, BUBBLES WERE OBSERVED DURING CORTEX REMOVAL USING AN OPHTHALMIC IRRIGATION¿ASPIRATION HANDPIECE. THE SURGERY WAS COMPLETED THE SAME DAY USING AN ALTERNATIVE HANDPIECE, AND THERE WAS NO HARM TO THE PATIENT. THIS REPORT PERTAINS TO FOUR OF SEVEN REPORTS FROM THE SAME FACILITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24629116 ↗
• MalfunctionMar 18, 2026Suction Failure

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING A REFRACTIVE LENS EXCHANGE (RLE) SURGERY; WHILE REPLACING THE NATURAL LENS WITH AN ACRYLIC LENS IN THE RIGHT EYE, BUBBLES WERE OBSERVED DURING CORTEX REMOVAL USING AN OPHTHALMIC IRRIGATION¿ASPIRATION HANDPIECE. THE SURGERY WAS COMPLETED THE SAME DAY USING AN ALTERNATIVE HANDPIECE, AND THERE WAS NO HARM TO THE PATIENT. THIS REPORT PERTAINS TO TWO OF SEVEN REPORTS FROM THE SAME FACILITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24625543 ↗
• MalfunctionMar 18, 2026Suction Failure

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING A REFRACTIVE LENS EXCHANGE (RLE) SURGERY; WHILE REPLACING THE NATURAL LENS WITH AN ACRYLIC LENS IN THE RIGHT EYE, BUBBLES WERE OBSERVED DURING CORTEX REMOVAL USING AN OPHTHALMIC IRRIGATION¿ASPIRATION HANDPIECE. THE SURGERY WAS COMPLETED THE SAME DAY USING AN ALTERNATIVE HANDPIECE, AND THERE WAS NO HARM TO THE PATIENT. THIS REPORT PERTAINS TO ONE OF SEVEN REPORTS FROM THE SAME FACILITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24625491 ↗
• MalfunctionNov 24, 2025Suction Failure; Suction Failure

  A PHYSICIAN REPORTED DURING SETUP THAT ASPIRATION ISSUE OF AN OPHTHALMIC POLYMER TIP OCCURRED. THE SURGERY WAS PERFORMED AND COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THE PROCEDURE TYPE WAS UNKNOWN. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23630430 ↗
• MalfunctionJun 16, 2025Suction Failure; Suction Failure

  A PHARMACIST REPORTED THAT DURING CATARACT SURGERY, AN OPHTHALMIC HANDPIECE WOULD NOT EXHIBIT ASPIRATION AND ULTRASOUND WAS INEFFECTIVE DURING PHACOEMULSIFICATION STEP. NO PATIENT HARM HAS BEEN REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND NONE RECEIVED TILL DATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22209994 ↗
• MalfunctionJun 11, 2024Sharp Edges; Sharp Edges

  A CUSTOMER REPORTED THAT BEFORE SURGERY, AN OPHTHALMIC TIP FOUND TO BE SHARP. THE PROCEDURE WAS COMPLETED. THERE WAS NO PATIENT IMPACT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19507672 ↗
• InjuryJun 10, 2024Sharp Edges; Sharp Edges

  A CUSTOMER REPORTED THAT DURING A SURGERY AN OPHTHALMIC IRRIGATION AND ASPIRATION TIP WAS FOUND TO BE SHARP AND THE PATIENT EXPERIENCED POSTURE CAPSULE RUPTURE. SURGEON USED ANOTHER PRODUCT TO COMPLETE THE PROCEDURE. PROCEDURE DETAILS WERE NOT PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED NONE RECEIVED TILL DATE.

  Patient problems: Capsular Bag Tear

  MAUDE report 19496430 ↗
• MalfunctionMar 1, 2024Suction Problem; Suction Problem

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING IRRIGATION ASPIRATION (I/A) STEP OF A CATARACT PROCEDURE THE IRRIGATION ASPIRATION HANDPIECE DID NOT BUILD UP VACUUM. THE PROCEDURE WAS COMPLETED WITH ANOTHER I/A HANDPIECE THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18815407 ↗
• MalfunctionJan 3, 2024Suction Failure; Suction Failure

  A HEALTH CARE PROFESSIONAL REPORTED THAT AN OPHTHALMIC IRRIGATION/ASPIRATION TIP HAD AN ISSUE WITH LOSS OF VACUUM. IT WAS BELIEVED THAT THE IRRIGATION/ASPIRATION TIP WAS THE ISSUE. IT MIGHT BE DUE TO OVER TIGHTENING THE TIP OR A DEFECTIVE TIP. THE SURGERY WAS COMPLETED ON THE SAME DAY. THE PROCEDURE DETAILS WERE NOT REPORTED. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18434875 ↗
• MalfunctionJul 28, 2023Defective Component; Defective Component

  A HEALTHCARE PROFESSIONAL REPORTED THAT AN OPHTHALMIC HANDPIECE EXHIBITED BURR ON THE ASPIRATION HANDPIECE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17413278 ↗
• InjuryNov 1, 2021Sharp Edges; Sharp Edges

  A PHYSICIAN REPORTED HE BROKE THE POSTERIOR CAPSULE WITH THE SHARP EDGE OF THE INFUSION CANNULA DURING THE FIRST CATARACT SURGICAL CASE. ADDITIONAL INFORMATION WAS REQUESTED; HOWEVER, NONE HAS BEEN RECEIVED TO DATE.

  Patient problems: Capsular Bag Tear

  MAUDE report 12729653 ↗
• InjuryJun 30, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A SURGEON REPORTED THAT A PATIENT EXPERIENCED TOXIC ANTERIOR SEGMENT SYNDROME (TASS) FOLLOWING A CATARACT EXTRACTION PROCEDURE AND LASER TREATMENT. UPON POST-OPERATIVE EXAMINATION OF THE PATIENT, THE SURGEON NOTED 3+ AQUEOUS CELL, LESS THAN 1+ CONJUNCTIVAL INFLAMMATION, LESS THAN 1+ VITREOUS INFLAMMATION AND AQUEOUS FIBRIN. NO CULTURES WERE PERFORMED AND NO INTERVENTION TREATMENT WAS PROVIDED. THE PATIENT'S SYMPTOMS HAVE RESOLVED WITHOUT ANY ADDITIONAL TREATMENT. THIS REPORT REPRESENTS THE FIRST OF THREE PATIENTS FOR THIS SURGEON.

  Patient problems: Conjunctivitis; Inflammation; Toxic Anterior Segment Syndrome (TASS); Uveitis; Vitritis

  MAUDE report 12094648 ↗
• InjuryJun 29, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A SURGEON REPORTED A PATIENT EXPERIENCED TOXIC ANTERIOR SEGMENT SYNDROME (TASS) FOLLOWING A CATARACT EXTRACTION PROCEDURE. THE PATIENT PRESENTED POST-OPERATIVE DAY ONE WITH MORE ANTERIOR CHAMBER REACTION. UPON EXAMINATION OF THE PATIENT, THE SURGEON NOTED 2+ AQUEOUS CELL, LESS THAN 1+ CONJUNCTIVAL INFLAMMATION AND LESS THAN 1+ VITREOUS INFLAMMATION. NO CULTURES WERE PERFORMED. THE PATIENT'S SYMPTOMS HAVE RESOLVED WITHOUT ANY ADDITIONAL TREATMENT. THIS REPORT REPRESENTS THE SECOND OF THREE PATIENTS FOR THIS SURGEON.

  Patient problems: Conjunctivitis; Inflammation; Toxic Anterior Segment Syndrome (TASS); Uveitis; Vitritis

  MAUDE report 12087387 ↗
• InjuryJun 29, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A SURGEON REPORTED A PATIENT EXPERIENCED TOXIC ANTERIOR SEGMENT SYNDROME (TASS) FOLLOWING A CATARACT EXTRACTION PROCEDURE. THE PATIENT PRESENTED POST-OPERATIVE DAY ONE WITH NO SIGNS OF SYMPTOMS. UPON EXAMINATION OF THE PATIENT, THE SURGEON NOTED 3+ AQUEOUS CELL. THE PATIENT WAS PRESCRIBED WITH POST-OPERATIVE STEROID EYE DROPS. NO CULTURES WERE PERFORMED. THE PATIENT'S SYMPTOMS HAVE RESOLVED WITHOUT ANY ADDITIONAL TREATMENT. THIS REPORT REPRESENTS THE THREE OF THREE PATIENTS FOR THIS SURGEON.

  Patient problems: Toxic Anterior Segment Syndrome (TASS); Uveitis

  MAUDE report 12086563 ↗
• InjuryJun 29, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A SURGEON REPORTED THAT A PATIENT EXPERIENCED TOXIC ANTERIOR SEGMENT SYNDROME (TASS) FOLLOWING A CATARACT EXTRACTION PROCEDURE. THE PATIENT PRESENTED POST-OPERATIVE DAY ONE WITH SIGNIFICANT INFLAMMATION, 3+AQUEOUS CELL NOTED AND LESS THAN 1+VITREOUS INFLAMMATION. NO CULTURES WERE PERFORMED. THE PATIENT WAS TREATED WITH ADDITIONAL STEROID EYE DROPS. THE PATIENT'S SYMPTOMS HAVE RESOLVED. THIS REPORT REPRESENTS THE SECOND OF THREE PATIENTS FOR THIS SURGEON.

  Patient problems: Toxic Anterior Segment Syndrome (TASS); Uveitis; Vitritis

  MAUDE report 12085969 ↗
• InjuryJun 29, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A SURGEON REPORTED A PATIENT EXPERIENCED TOXIC ANTERIOR SEGMENT SYNDROME (TASS) FOLLOWING A CATARACT EXTRACTION PROCEDURE. THE PATIENT PRESENTED POST-OPERATIVE DAY ONE WITH INFLAMMATION, HYPOPYON AND CORNEAL EDEMA. UPON EXAMINATION OF THE PATIENT, THE SURGEON NOTED 4+ AQUEOUS CELL, AND 3+ VITREOUS INFLAMMATION. THE PATIENT WAS TREATED WITH ADDITIONAL STEROID EYE DROPS. NO CULTURES WERE PERFORMED. THE PATIENT'S SYMPTOMS HAVE RESOLVED. THIS REPORT REPRESENTS THE THREE OF THREE PATIENTS FOR THIS SURGEON.

  Patient problems: Corneal Edema; Fibrosis; Hypopyon; Toxic Anterior Segment Syndrome (TASS); Uveitis; Vitritis

  MAUDE report 12085673 ↗