Laureate 8065750541Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 00380657505418), received between Apr 7, 2021 and Dec 29, 2025 — classified as 2 injuries, 20 malfunctions.

The most frequently reported specific device problem is “Complete Blockage” (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. 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 22 most recent of 22 reports, 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 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 ↗
• 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 ↗
• 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 ↗
• MalfunctionNov 10, 2023Complete Blockage; Complete Blockage

  THE NON-HEALTH CARE PROFESSIONAL REPORTED THAT SYSTEM KEPT EMITTING A DRIPPING ALARM SOUND DURING THE SURGERY. THE SURGERY WAS COMPLETED ON THE SAME DAY AFTER REPLACING THE PRODUCT WITH NEW ONE. THERE WAS NO PATIENT HARM. THE PROCEDURE TYPE WAS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18108502 ↗
• MalfunctionAug 22, 2023Disconnection; Disconnection

  AS A RESULT OF AN INTERNAL REVIEW OF THE FILE, IT WAS DETERMINED THAT THE INFORMATION PROVIDED FOR THIS EVENT CASSETTE TUBING DOES NOT REPRESENT A REPORTABLE DEVICE MALFUNCTION AND IT IS NOT LIKELY THAT A RECURRENCE WOULD RESULT IN SERIOUS INJURY. THE INITIAL REPORT WAS SUBMITTED IN ERROR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17595638 ↗
• MalfunctionAug 14, 2023Inability to Irrigate; Inability to Irrigate

  A CUSTOMER REPORTED THAT ASPIRATION FAILURE WAS OCCURRED AND ABNORMAL NOISE WAS HEARD WHEN PERFORMED ASPIRATION DURING CATARACT SURGERY. THE PROCEDURE WAS COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17539058 ↗
• MalfunctionAug 7, 2023Fitting Problem; Fitting Problem

  A PHYSICIAN REPORTED THAT FLUIDICS MANAGEMENT SYSTEM WERE NOT CONNECTED PROPERLY WITH IRRIGATION/ASPIRATION AND PHACO HANDPIECE DURING SURGERY. THE SURGERY WAS COMPLETED AFTER REPLACING THE PRODUCT WITH NEW ONE. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17468656 ↗
• MalfunctionDec 9, 2022Air/Gas in Device; Air/Gas in Device

  A CUSTOMER REPORTED A LARGE NUMBER OF BUBBLES APPEARED IN THE ANTERIOR CHAMBER WHICH AFFECTED THE SURGICAL VISION DURING THE PROCEDURE FOR CATARACT PHACOEMULSIFICATION AND INTRAOCULAR LENS IMPLANTATION. BUBBLES DURING THE PROCEDURE COULD NOT BE DETERMINED WHETHER IT WAS THE DETERIORATION OF THE LIQUID IN THE PRODUCT OR THE PROCEDURE. THE PRODUCT WAS REPLACED. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15949878 ↗
• MalfunctionOct 17, 2022Complete Blockage; Complete Blockage

  A PHYSICIAN REPORTED THE HANDPIECE WAS NOT FUNCTIONING DURING A CATARACT SURGERY (WITH IOL IMPLANT). THE PHYSICIAN TRIED TO CHANGE THE TIP OF THE HANDPIECE BUT THE PROBLEM WAS NOT RESOLVED. A MESSAGE APPEARED ON THE SCREEN INDICATING THAT THE TUBINGS OF CASSETTE WERE BLOCKED WHEN THE HANDPIECE WAS CHANGED AND TESTED. THE CASSETTE WAS THEN CHANGED. THERE WAS NO REPORT OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15615231 ↗
• MalfunctionAug 3, 2022Suction Failure; Suction Failure

  A PHARMACIST REPORTED A CASSETTE STOPPED ASPIRATING (STAGE UNKNOWN) DURING THE CATARACT PROCEDURE. THE CASSETTE WAS REPLACED AND THE PROCEDURE WAS COMPLETED. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15154584 ↗
• MalfunctionMar 25, 2022Fluid/Blood Leak; Suction Failure; Fluid/Blood Leak; Suction Failure

  A CUSTOMER REPORTED THERE WAS NO NEGATIVE PRESSURE DURING THE PROCEDURE AND WHEN THE SURGEON CHECKED THE CASSETTE, IT WAS FOUND THAT THE JOINT WAS LEAKING. THE PRODUCT WAS REPLACED AND THE PROCEDURE WAS COMPLETED. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13906635 ↗
• MalfunctionNov 12, 2021Improper Flow or Infusion; Improper Flow or Infusion

  A PHYSICIAN REPORTED THE FLUID FLOW WAS UNSTABLE AND UNABLE TO MAINTAIN THE ANTERIOR CHAMBER WELL DURING A CATARACT PROCEDURE. THE PRODUCT WAS REPLACED WITH ANOTHER ONE AND THE PROCEDURE WAS COMPLETED. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: Intraocular Pressure Decreased; No Clinical Signs, Symptoms or Conditions

  MAUDE report 12805833 ↗
• MalfunctionOct 13, 2021Suction Failure; Suction Failure

  ADDITIONAL INFORMATION WAS RECEIVED INDICATING THE EVENT OCCURRED BEFORE THE CATARACT PROCEDURE. THE PHACOEMULSIFICATION (PHACO) KIT WAS REPLACED AND THE PROCEDURE WAS COMPLETED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12627239 ↗
• MalfunctionApr 7, 2021No Flow; No Flow

  A PHYSICIAN REPORTED THAT THERE WAS NO FLUID COMING OUT FROM THE TUBING DURING SURGERY. THE PRODUCT WAS REPLACED AND THE SURGERY WAS COMPLETED. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11629431 ↗