Constellation 8065751155Recalls & reported problems

Summary

The FDA's MAUDE database contains 220 adverse event reports that list this exact device (DI 00380657511556), received between Mar 19, 2021 and Sep 23, 2026 — classified as 14 injuries, 206 malfunctions.

The most frequently reported specific device problem is “Suction Failure” (56 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Apr 28, 2025Open, Classified

   Due to the potential that some units within specific lots were damaged during the manufacturing process. The area of damage is within the same area of the lidding. While the damage in the lidding is visibly noticeable, due to risk of sterility being compromised.

   Z-2109-2025 · Root cause: Under Investigation by firm · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 220 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 23, 2026Suction Problem

  A physician reported that ultrasound could not be used due to high aspiration resistance during the surgery. The procedure type was unknown. The surgery was completed on the same day after replacing the product with another one. There was no patient contact.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50870520 ↗
• MalfunctionAug 24, 2026Suction Problem

  A physician reported that, at the time of surgery, the cassette was found to be defective as it was unable to aspirate. The procedure type was unknown. The procedure was completed on same day after replacing the product with new one. There was no patient impact.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50401854 ↗
• MalfunctionMar 3, 2026Obstruction of Flow

  A NURSE REPORTED THAT ASPIRATION TUBING WAS BLOCKED DURING CATARACT SURGERY (WITHOUT INTRAOCULAR LENSES IMPLANT (IOL)). 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 24493676 ↗
• MalfunctionFeb 25, 2026Material Separation

  A HEALTH CARE PROFESSIONAL REPORTED THAT FLEXIBLE TUBES WAS DISCONNECTED FROM THE METAL TIPS AND STERILIZED DURING CATARACT SURGERY. THE SURGERY WAS COMPLETED AFTER REPLACING IT WITH A NEW PRODUCT. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24442547 ↗
• MalfunctionFeb 13, 2026Leak/Splash

  A PHYSICIAN REPORTED THAT THE LEAKAGE OCCURRED FROM THE CASSETTE DURING SURGERY. THE PROCEDURE TYPE WAS UNKNOWN. THE PROCEDURE WAS COMPLETED ON SAME DAY BY REPLACING THE PRODUCT WITH NEW ONE. THERE WAS NO PATIENT CONTACT AND NO INFORMATION ABOUT PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24330509 ↗
• MalfunctionFeb 3, 2026Suction Problem

  A PHYSICIAN REPORTED THAT THE ASPIRATION DID NOT WORK DURING SURGERY. THE PROCEDURE TYPE WAS UNKNOWN. THE PROCEDURE WAS COMPLETED ON SAME DAY BY REPLACING THE PRODUCT WITH NEW ONE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24243627 ↗
• MalfunctionJan 30, 2026Leak/Splash

  A NURSE REPORTED THAT CASSETTE HAD LEAKED WATER DURING CATARACT WITHOUT INTRA OCULAR LENS IMPLANT SURGERY. THE SURGERY WAS COMPLETED ON THE SAME DAY AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24223091 ↗
• InjuryJan 12, 2026Adverse Event Without Identified Device or Use Problem

  A PHYSICIAN REPORTED THAT AN ERROR MESSAGE WAS DISPLAYED INDICATING THAT THERE WAS A PROBLEM DETECTED WITH DRAINAGE PUMP, INFUSION/IRRIGATION AND SUCTION FUNCTIONS WERE UNAVAILABLE DURING CATARACT SURGERY WITH INTRAOCULAR LENS IMPLANTATION. THE SURGERY WAS CANCELLED, AND THE EQUIPMENT WAS REPAIRED ON THE SAME DAY. REOPERATION HAS BEEN PERFORMED ON THE FOLLOWING DAY AND WAS COMPLETED WITHOUT AFFECTING THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED. NONE RECEIVED TILL DATE. THIS REPORT PERTAINS TO THE CASSETTE INVOLVED IN THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24033969 ↗
• MalfunctionJan 8, 2026Suction Problem

  A PHYSICIAN REPORTED THAT THE ASPIRATION WAS POOR DURING SURGERY. THE PROCEDURE TYPE WAS UNKNOWN. THE SURGERY WAS COMPLETED ON THE SAME DAY AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24000457 ↗
• MalfunctionDec 31, 2025Product Quality Problem; Product Quality Problem

  A NON-HEALTH CARE PROFESSIONAL REPORTED THAT IRRIGATION AND ASPIRATION HANDPIECE SLEEVE HAD DEFECT DURING CATARACT SURGERY WITHOUT INTRAOCULAR LENS IMPLANT. THE SURGERY WAS COMPLETED AFTER REPLACING WITH SPARE SLEEVE. THERE WAS NO INFORMATION ABOUT PATIENT IMPACT.

  Patient problems: Insufficient Information

  MAUDE report 23932394 ↗
• MalfunctionDec 24, 2025Leak/Splash; Leak/Splash

  A PHYSICIAN REPORTED THAT THERE WAS LEAKAGE FROM THE BACKSIDE OF THE CASSETTE DUE TO THE LOOSE RUBBER DURING CALIBRATION. THE PROCEDURE DETAILS WERE UNKNOWN. THERE WAS NO REPORTED INFORMATION ABOUT PATIENT IMPACT.

  Patient problems: Insufficient Information

  MAUDE report 23887441 ↗
• MalfunctionDec 13, 2025Suction Problem; Suction Problem

  A PHYSICIAN REPORTED THAT ASPIRATION ISSUE OCCURRED DURING ULTRASOUND (US) SURGERY. THE SURGERY WAS COMPLETED ON SAME DAY BY REPLACING THE CASSETTE. THE SURGERY TYPE WAS UNKNOWN. THE PRODUCT WAS CONTACTED WITH PATIENT BUT THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23797843 ↗
• MalfunctionDec 11, 2025Suction Problem; Suction Problem

  A HEALTHCARE PROFESSIONAL REPORTED THAT THE CASSETTE DID NOT RESPOND TO ULTRASOUND OR DIATHERMY DURING SURGERY. THE PROCEDURE TYPE WAS UNKNOWN. THE SURGERY WAS COMPLETED AFTER REPLACING THE CASSETTE WITH ANOTHER ONE. THERE WAS NO PATIENT IMPACT. THIS REPORT PERTAINS TO THE CASSETTE INVOLVED IN THIS REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23775400 ↗
• MalfunctionNov 28, 2025Suction Problem; Suction Problem

  A PHYSICIAN REPORTED THAT ASPIRATION FAILURE OCCURRED, AND PROPER ASPIRATION COULD NOT BE ACHIEVED DURING POLISHING AFTER INTRAOCULAR LENS IMPLANT (IOL) INSERTION DURING CATARACT SURGERY. THE SURGERY WAS COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23671588 ↗
• MalfunctionNov 25, 2025Leak/Splash; Leak/Splash

  A CUSTOMER REPORTED THAT THE CASSETTE WAS LEAKING BEFORE VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED ON THE SAME DAY AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WAS NO PATIENT CONTACT WITH THE PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23646845 ↗
• MalfunctionNov 7, 2025Inability to Irrigate; Inability to Irrigate

  A PHYSICIAN REPORTED THAT IRRIGATION FAILURE OCCURRED AND THE SOLUTION DID NOT FLOW AT ALL DURING CATARACT SURGERY (WITH IOL IMPLANT). THE SURGERY WAS COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THE SURGERY WAS COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23497964 ↗
• MalfunctionNov 7, 2025Leak/Splash; Failure to Prime; Leak/Splash; Failure to Prime

  A PHYSICIAN REPORTED THAT PRIMING TEST FAILURE OCCURRED AND BALANCED SALT SOLUTION LEAKED FROM THE BOTTOM OF THE CASSETTE DURING CALIBRATION. AN ERROR OCCURRED ON THE CONSOLE BEFORE SETUP, BUT THERE WAS NO ERROR MESSAGE. THE SURGERY WAS PERFORMED AND COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WAS NO INFORMATION ABOUT PATIENT IMPACT.

  Patient problems: Insufficient Information

  MAUDE report 23497764 ↗
• MalfunctionOct 24, 2025Infusion or Flow Problem; Infusion or Flow Problem

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT FLUID WAS CONTINUOUSLY FLOWING OUT OF IRRIGATION PORTS OF HANDPIECE DURING CATARACT (WITH INTRAOCULAR LENS IMPLANT) SURGERY. THE SURGERY WAS SUCCESSFULLY COMPLETED ON SAME DAY. THERE WAS NO INFORMATION ABOUT PATIENT IMPACT.

  Patient problems: Insufficient Information

  MAUDE report 23378205 ↗
• MalfunctionOct 23, 2025Suction Problem; Suction Problem

  A PHYSICIAN REPORTED THAT ASPIRATION PRESSURE DID NOT INCREASE DURING CATARACT SURGERY (WITH INTRAOCULAR LENSES IMPLANT). THE SURGERY WAS COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23365731 ↗
• MalfunctionOct 23, 2025Leak/Splash; Leak/Splash

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT THE CASSETTE PULLS LIQUID WHEN CONNECTED BEFORE THE SURGERY. THE SURGERY DETAILS AND PATIENT IMPACT DETAILS WERE UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 23364802 ↗
• MalfunctionSep 15, 2025Obstruction of Flow; Obstruction of Flow

  A PHYSICIAN REPORTED THAT THE ULTRASOUND TIP COULD NOT BE OSCILLATED DURING THE SURGERY. THE SURGERY WAS COMPLETED ON SAME DAY BY REPLACING THE PRODUCT. THE PROCEDURE TYPE WAS UNKNOWN. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23048900 ↗
• MalfunctionSep 12, 2025Obstruction of Flow; Obstruction of Flow

  A CUSTOMER REPORTED THAT DURING CATARACT SURGERY (WITHOUT INTRA OCULAR LENS IMPLANTATION), THERE WAS FREQUENT FAILURES WITH AN ALARM AS THERE WAS SOME PROBLEM IN ASPIRATION LINE (ERROR APPEARED ON THE SCREEN STATING THERE WERE PROBLEMS WITH THE SUCTION). THE PROCEDURE WAS COMPLETED ON THE SAME DAY BY CHANGING OF PACKS AS THE PROBLEM OCCURRED REPEATEDLY WITH THE SECOND PACK AS WELL. THERE WAS NO PATIENT CONTACT WITH SUSPECT PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23038368 ↗
• MalfunctionSep 12, 2025Obstruction of Flow; Obstruction of Flow

  A CUSTOMER REPORTED THAT DURING CATARACT SURGERY (WITHOUT INTRA OCULAR LENS IMPLANTATION), THERE WAS FREQUENT FAILURES WITH AN ALARM AS THERE WAS SOME PROBLEM IN ASPIRATION LINE (ERROR APPEARED ON THE SCREEN STATING THERE WERE PROBLEMS WITH THE SUCTION). THE PROCEDURE WAS COMPLETED ON THE SAME DAY BY CHANGING OF PACKS AS THE PROBLEM OCCURRED REPEATEDLY WITH THE SECOND PACK AS WELL. THERE WAS NO PATIENT CONTACT WITH SUSPECT PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23038312 ↗
• MalfunctionSep 11, 2025Suction Problem; Suction Problem

  A PHYSICIAN REPORTED THAT ASPIRATION FAILURE OCCURRED DURING ULTRASOUND (US) AND IRRIGATION/ASPIRATION (IA) MODE OF SURGERY. THE PROCEDURE TYPE WAS UNKNOWN. THE SURGERY WAS COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THE INVOLVED EYE AND THE PATIENT IDENTIFIER ARE NOT AVAILABLE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23024376 ↗
• MalfunctionSep 8, 2025Suction Failure; Suction Failure

  A PHYSICIAN REPORTED ASPIRATION FAILURE OCCURRED WHEN THE HANDPIECE (PHACOEMULSIFICATION TIP) WAS USED DURING ULTRASOUND MODE (US) FOR CATARACT SURGERY (WITH INTRAOCULAR LENS IMPLANT). THE SURGERY WAS COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22993960 ↗