LaureateRecalls & reported problems across all models

We found 2 models of Laureate by Alcon Laboratories, Inc. in the FDA's device registry (GUDID). Together they are named in 34 adverse event reports in the FDA's MAUDE database, received between Apr 7, 2021 and Dec 29, 2025 — classified as 2 injuries, 32 malfunctions.

The most frequently reported specific device problem is “Failure to Cut” (11 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported Laureate problems

Laureate models

2 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Laureate 8065750541

  Unit, phacofragmentation
  22 reports
• Laureate 8065750470

  Unit, phacofragmentation
  12 reports

Recent Laureate adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionDec 29, 2025Obstruction of Flow; Obstruction of Flow

  A NURSE REPORTED THAT INFUSION TUBING THAT CONNECTED TO THE CASSETTE WAS BLOCKED DURING CATARACT (WITHOUT INTRAOCULAR LENS IMPLANT) SURGERY. THE SURGERY WAS SUCCESSFULLY COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WAS NO INFORMATION ABOUT THE PATIENT IMPACT.

  Patient problems: Insufficient Information

  MAUDE report 23904697 ↗
• MalfunctionDec 24, 2025Failure to Cut; Failure to Cut

  A CUSTOMER REPORTED THAT, DURING ANTERIOR VITRECTOMY SURGERY AN OPHTHALMIC HANDPIECE DIDN'T CUT, AND NO CUTTING SOUND WAS HEARD. IT IS UNKNOWN WHETHER THE SURGERY WAS COMPLETED. PATIENT HARM WAS NOT REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, NONE RECEIVED TILL DATE.

  Patient problems: Insufficient Information

  MAUDE report 23886697 ↗
• MalfunctionDec 23, 2025Suction Problem; Suction Problem

  A CUSTOMER REPORTED VIA HEALTH AUTHORITY THAT IT WAS FOUND THAT THE BASIC INFUSION PACK HAD INSUFFICIENT NEGATIVE PRESSURE UPON CONNECTION AND USE DURING CATARACT SURGERY WITH INTRAOCULAR LENS IMPLANT. THE PROCEDURE WAS COMPLETED AFTER REPLACEMENT OF PRODUCT WITH NEW ONE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23878193 ↗
• InjuryJul 3, 2025Fluid/Blood Leak; Failure to Prime; Suction Problem; Fluid/Blood Leak; Failure to Prime; Suction Problem

  A CUSTOMER REPORTED VIA REGULATORY AUTHORITY THAT TEST DID NOT PASS AND THERE WAS WATER LEAKAGE AT THE CONNECTION BETWEEN FLUIDICS MANAGEMENT SYSTEM (FMS) AND DEVICE AND CASSETTE CANNOT BE TIGHTLY CLOSED TO FORM A GOOD NEGATIVE PRESSURE DURING CATARACT PHACOEMULSIFICATION AND IOL (INTRA OCULAR LENS) IMPLANTATION SURGERY. CONSIDERING THE LONG EXPOSURE TIME OF THE CORNEA DURING THE OPERATION AND THE DAMAGE TO THE CORNEAL ENDOTHELIUM THE CASSETTE (FMS) WAS REPLACED. THE ANTERIOR CHAMBER REACTIONS WERE INCREASED DUE TO SURGERY TIME EXTENSION AFFECTING THE POST OPERATIVE VISUAL ACUITY IMPROVEMENT.

  Patient problems: Blurred Vision; Corneal Endothelial Cell Loss; Intraocular Pressure Decreased

  MAUDE report 22398675 ↗
• MalfunctionJun 27, 2025Complete Blockage; Complete Blockage

  A NON-HEALTHCARE PROFESSIONAL REPORTED VIA REGULATORY AUTHORITY THAT BLOCKAGE OF THE TUBING AND THE NEGATIVE PRESSURE WAS DECREASED DURING CATARACT SURGERY (WITHOUT INTRAOCULAR LENS IMPLANT). THE SURGERY WAS SUCCESSFULLY COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22345815 ↗
• MalfunctionJan 17, 2025Fluid/Blood Leak; Blocked Connection; Fluid/Blood Leak; Blocked Connection

  A HEALTHCARE PROFESSIONAL REPORTED THAT THE CASSETTE WAS BLOCKED AND LEAKING WATER DURING THE CATARACT [WITHOUT INTRAOCULAR LENS (IOL) IMPLANT] SURGERY. THE SURGERY WAS COMPLETED ON SAME DAY BY REPLACING THE PRODUCT. THERE WAS NO REPORT OF PATIENT IMPACT.

  Patient problems: Insufficient Information

  MAUDE report 21176970 ↗
• MalfunctionJan 7, 2025Infusion or Flow Problem; Infusion or Flow Problem

  ADDITIONAL INFORMATION RECEIVED THAT THE EVENT TIMING WAS CORRECTED FROM (DURING SURGERY TO DURING CALIBRATION) FOR THE EVENT WATER FLOW OBSTRUCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21089234 ↗
• MalfunctionAug 25, 2024Failure to Cut; Failure to Cut

  A PHYSICIAN REPORTED THAT BEFORE VITRECTOMY SURGERY AN OPHTHALMIC OPERATING HANDPIECE NOT CUTTING. THE SURGERY WAS COMPLETED ON THE SAME DAY BY AN ALTERNATIVE PROCEDURE. NO PATIENT IMPACT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20061072 ↗
• InjuryJun 14, 2024Connection Problem; Priming Problem; Connection Problem; Priming Problem

  A HEALTH AUTHORITY REPORTED THAT THE POSTOPERATIVE CORNEAL EDEMA AND OPACITY, UNABLE TO IMPROVE PATIENT'S VISION DURING CATARACT SURGERY WITH INTRAOCULAR IMPLANTATION SURGERY. DURING USE, THE INSTRUMENT WAS TURNED ON AND THE ACCESSORIES WERE CONNECTED FOR TESTING, BUT IT WAS FOUND THAT THE TEST DID NOT PASS. AFTER MULTIPLE TESTS, IT WAS PASSED, THEN UNSTABLE NEGATIVE PRESSURE IN THE ANTERIOR CHAMBER OCCURRED DURING SURGERY. THIS RESULTED IN PROLONGED SURGERY TIME, PROLONGED EXPOSURE OF THE CORNEA DURING SURGERY AND DAMAGE TO THE CORNEAL ENDOTHELIUM. AFTER CHECKING THE CASSETTE, THERE IS NO OVERFLOW OR CHANGE IN POSITION OF THE CASSETTE. CONSIDERING THAT THE LID OF THE CASSETTE WAS UNEVEN, RESULTING IN LOOSE CONNECTION WITH DEVICE. A NEW CASSETTE WAS REPLACED AND THE SURGERY WAS COMPLETED. NO SIMILAR SITUATIONS OCCURRED AGAIN.

  Patient problems: Blurred Vision; Corneal Clouding/Hazing; Corneal Edema; Corneal Endothelial Cell Loss; Intraocular Pressure Decreased; Tissue Breakdown

  MAUDE report 19537634 ↗
• MalfunctionMar 26, 2024Failure to Cut; Failure to Cut

  A CUSTOMER REPORTED THAT AN OPHTHALMIC HANDPIECE HAD NO CUTTING IN VITRECTOMY MODE IN CATARACT SURGERY. DETAILS OF PROCEDURE WERE NOT REPORTED. THERE WAS NO PATIENT HARM. ADDITIONAL DETAILS HAS BEEN REQUESTED AND NONE RECEIVED TILL DATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18976986 ↗
• MalfunctionMar 6, 2024Failure to Cut; Failure to Cut

  A PHYSICIAN REPORTED THAT DURING CATARACT PROCEDURE OPHTHALMIC HANDPIECE WAS NOT CUTTING. THE PROCEDURE COMPLETED BY REPLACING WITH ANOTHER HANDPIECE. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18844490 ↗
• MalfunctionJan 22, 2024Inability to Irrigate; Inability to Irrigate

  A CUSTOMER REPORTED THAT POSTERIOR SEGMENT PERFUSION FAILURE OCCURRED DURING SURGERY. THE PROCEDURE TYPE WAS UNKNOWN. AFTER REPLACING THE CASSETTE, STILL THE FAILURE PERSISTED. MANUAL PRESSURE WAS APPLIED USING A PRESSURE BAG AND THE SURGERY WAS COMPLETED. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18551010 ↗
• MalfunctionDec 22, 2023Inability to Irrigate; Inability to Irrigate

  A PHYSICIAN REPORTED THAT THERE WAS A DECREASE IN THE STABILITY OF THE ANTERIOR CHAMBER DURING VITRECTOMY SURGERY ALSO THERE WAS A DECREASE IN INFUSION FLUID FLOW RATE AND INSUFFICIENT PERFUSION OBSERVED, THERE WAS NO GAS TO ENTER THE BOTTLE THROUGH GAS FILTER PORT THEY TRIED TO INCREASE THE BOTTLE HEIGHT BUT STILL THE PROBLEM DID NOT SOLVE. THE PROCEDURE WAS COMPLETED ON THE SAME DAY. THE PATIENT HARM DETAILS WAS NOT REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 18384141 ↗
• MalfunctionDec 4, 2023No Flow; No Flow

  A NURSE REPORTED THAT INSUFFICIENT PERFUSION (NO LIQUID FLOWING OUT), NO GAS ENTERING THE GAS FILTER PORT DURING CATARACT SURGERY (PHACOEMULSIFICATION MODE). THE SURGERY WAS COMPLETED ON THE SAME DAY.THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18264204 ↗
• MalfunctionNov 25, 2023No Flow; No Flow

  ADDITIONAL INFORMATION WAS RECEIVED PATIENT DID NOT EXPERIENCE ANY HYPOPYON, NO IRITIS OR UVEITIS AND THERE WAS NO MEDICAL OR SURGICAL INTERVENTION REQUIRED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18207582 ↗

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