LIQUID OPTICS INTERFACE 0180-1201Recalls & reported problems

Summary

The FDA's MAUDE database contains 51 adverse event reports that list this exact device (DI 05050474609778), received between Aug 15, 2019 and Aug 28, 2026 — classified as 2 injuries, 49 malfunctions.

The most frequently reported specific device problem is “Decrease in Suction” (37 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 25 most recent of 51 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 28, 2026Contamination

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50508778 ↗
• MalfunctionAug 28, 2026Contamination

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50508741 ↗
• MalfunctionAug 7, 2026Decrease in Suction

  Customer reported that their suction broke during scans and laser firing. Procedure was not completed successfully. No patient injury reported. Note: This is report 2 of 4.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50184047 ↗
• MalfunctionAug 7, 2026Decrease in Suction

  Customer reported that their suction broke during scans and laser firing. Procedure was not completed successfully. No patient injury reported. Note: This is report 1 of 4.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50184006 ↗
• MalfunctionAug 7, 2026Manufacturing, Packaging or Shipping Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50177710 ↗
• MalfunctionJan 9, 2026Break; Manufacturing, Packaging or Shipping Problem

  THE CUSTOMER REPORTED THAT THEIR LIQUID OPTICS INTERFACE HAD AN EYEPIECE THAT WAS FOUND TO BE LOOSE OUT OF THE BOX. THE PROCEDURE WAS COMPLETED WITH ANOTHER LIQUID OPTICS INTERFACE. NO FURTHER INFORMATION PROVIDED. FOLLOW-UP INFORMATION RECEIVED ON DECEMBER 15, 2025, INDICATED THAT THE STERILE BARRIER WAS OPEN AND THE PRODUCT CAME OUT OF THE PACKAGE, BUT IT WAS NOT LOOSE WITHIN THE PACKAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24030675 ↗
• InjuryOct 27, 2025Decrease in Suction; Failure to Sense; Decrease in Suction; Failure to Sense

  IT WAS REPORTED THAT A LIQUID OPTICS INTERFACE (LOI) DIRECTION ERROR WAS DISPLAYED AFTER NEGATIVE PRESSURE CONNECTION WHICH OCCURRED BEFORE LASER FIRED AND WAS UNABLE TO CONTINUE THE NEXT STEP. THEN, THERE WAS A LARGER WHITE BUBBLE ABOVE THE MARK POINT VISIBLE ON THE SCREEN, WHICH COULD BE SUCCESSFULLY IDENTIFIED AFTER REPLACING THE LOI. HOWEVER, THE PATIENT'S CONJUNCTIVA WAS RELAXED, THE NEGATIVE PRESSURE WAS REMOVED DURING THE CUTTING PROCESS, THE CUTTING FAILED TO COMPLETE, AND THE ASTIGMATISM RELEASE INCISION FAILED TO BE COMPLETED. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Chemosis; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23392567 ↗
• MalfunctionOct 20, 2025Decrease in Suction; Decrease in Suction

  THE CUSTOMER REPORTED THAT THERE WAS NO SUCTION ON THE LIQUID OPTICS INTERFACE (LOI) WHICH OCCURRED DURING DOCKING/PROCEDURE ACTIVATION AND DURING LASER TREATMENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23336988 ↗
• MalfunctionSep 10, 2025Decrease in Suction; Decrease in Suction

  THE CUSTOMER REPORTED RECURRING LOSS OF SUCTION DESPITE MULTIPLE ATTEMPTS AT REDOCKING, CAUSED BY A SMALL EYE FISSURE AND LOW PATIENT COOPERATION. THEY WERE ABLE TO REACH THE TREATMENT STAGE BUT LOST SUCTION DURING CAPSULOTOMY. THE PROCEDURE WAS STOPPED BECAUSE SUCTION COULD NOT BE MAINTAINED. NO PATIENT INJURIES OR ADDITIONAL SURGICAL INTERVENTIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23017862 ↗
• MalfunctionAug 26, 2025Contamination; Contamination

  CUSTOMER REPORTED DEBRIS WAS NOTED ON THE EYEPIECE DURING THE DOCKING/PROCEDURE ACTIVATION, AND SUCTION TO THE EYE WAS ACHIEVED. HOWEVER, THE LASER PROCEDURE WAS COMPLETED SUCCESSFULLY, AS A DIFFERENT KIT WAS USED. THERE WAS NO PATIENT INJURY OR SURGICAL INTERVENTION REQUIRED. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22900680 ↗
• InjuryJun 4, 2025Decrease in Suction; Decrease in Suction

  IT WAS REPORTED THAT THERE WAS A LOSS OF SUCTION DURING A PROCEDURE USING THE CATALYSE-I LASER. THE SUCTION WAS REESTABLISHED AND AT THE END IT WAS FOUND THAT THE ARCUATE INCISION HAD PERFORATED THE CORNEA, MAKING IT NECESSARY TO SUTURE THE INCISION. FOLLOW-UP INFORMATION REVEALED THAT THE PROCEDURE WAS COMPLETED USING A SINGLE LIQUID OPTICAL INTERFACE (LOI) CONE. THE PATIENT IS CURRENTLY WAITING FOR THE REMOVAL OF THE CORNEAL SUTURE. NO ADDITIONAL INFORMATION HAVE BEEN PROVIDED. THIS REPORT PERTAINS THE LIQUID OPTICS INTERFACE(LOI). A SEPARATE REPORT IS BEING SUBMITTED FOR THE CATALYSE SYSTEM .

  Patient problems: Corneal Perforation; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22146110 ↗
• MalfunctionApr 28, 2025Decrease in Suction; Decrease in Suction

  THIS REPORT SUMMARIZES 28 MALFUNCTION EVENTS. THE EVENT WAS RELATED TO SUCTION LOSS WHILE LASER WAS FIRING. THERE WERE NO PATIENT INJURIES REPORTED ASSOCIATED TO THE EVENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21923372 ↗
• MalfunctionJan 16, 2025Decrease in Suction; Decrease in Suction

  THIS REPORT SUMMARIZES 25 MALFUNCTION EVENTS. THE EVENTS WERE RELATED TO SUCTION LOSS DURING LASER FIRE. THERE WERE NO PATIENT INJURIES REPORTED ASSOCIATED TO THE EVENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21172942 ↗
• MalfunctionNov 27, 2024Contamination; Contamination

  CUSTOMER REPORTED DEBRIS ON THEIR LIQUID OPTICS INTERFACE (LOI). THE ISSUE WAS OBSERVED DURING DOCKING/PROCEDURE ACTIVATION. A NEW LOI WAS REQUIRED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20791978 ↗
• MalfunctionOct 28, 2024Decrease in Suction; Decrease in Suction

  THIS REPORT SUMMARIZES 21 MALFUNCTION EVENTS. THE EVENT WAS RELATED TO SUCTION LOSS WHILE LASER FIRING. THERE WERE NO PATIENT INJURIES REPORTED ASSOCIATED TO THE EVENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20553437 ↗
• MalfunctionOct 17, 2024Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT THE OUTER PACKAGING WAS INTACT, HOWEVER THE INNER PACKAGING OF THE PATIENT INTERFACE WAS NOT AND THE KIT WAS COMPROMISED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20476937 ↗
• MalfunctionOct 1, 2024Delivered as Unsterile Product; Manufacturing, Packaging or Shipping Problem; Delivered as Unsterile Product; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT THE PACKAGE LIQUID OPTICS INTERFACE (LOI) WAS OPENED AND THERE WAS A BREACH IN STERILITY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20348126 ↗
• MalfunctionJul 25, 2024Decrease in Suction; Decrease in Suction

  THIS REPORT SUMMARIZES 45 MALFUNCTION EVENTS. THE EVENT WAS RELATED TO SUCTION LOSS WHILE LASER FIRING. THERE WERE NO PATIENT INJURIES REPORTED ASSOCIATED TO THE EVENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19833951 ↗
• MalfunctionJul 23, 2024Contamination; Contamination

  IT WAS REPORTED THAT THE SURGEON FOUND FOREIGN PARTICLE WHEN DOCKING THE PATIENT EYE. THERE WAS NO DELAY IN TREATMENT OR OTHER INTERVENTIONS PERFORMED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19812394 ↗
• MalfunctionMay 13, 2024Contamination; Contamination

  IT WAS REPORTED THAT THERE WAS HAZE ON THE CONE OF THE LIQUID OPTICS INTERFACE (LOI). ATTEMPTS WERE MADE TO SEE IF THERE WAS ANY PATIENT CONTACT HOWEVER, NO RESPONSE WAS RECEIVED. THE PROCEDURE WAS COMPLETED BY SWITCHING TO A NEW LOI.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19305937 ↗
• MalfunctionApr 24, 2024Decrease in Suction; Decrease in Suction

  B5 - THIS REPORT SUMMARIZES 24 MALFUNCTION EVENTS. THE EVENTS WERE RELATED TO SUCTION LOSS DURING LASER FIRE. THERE WERE NO PATIENT INJURIES REPORTED ASSOCIATED TO THE EVENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19177728 ↗
• MalfunctionNov 20, 2023Decrease in Suction; Mechanical Problem; Decrease in Suction; Mechanical Problem

  IT WAS REPORTED THAT THERE WAS A LOSS OF SUCTION. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER INTERFACE. ACCORDING TO THE DOCTOR, THIS UNIT HAD A STEEPER TUBING INCLINATION THAN THE OTHERS. THROUGH FOLLOW-UP, IT WAS CONFIRMED THAT THE SUCTION LOSS OCCURRED DURING LASER FIRING. NO ADDITIONAL INFORMATION WAS RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18177342 ↗
• MalfunctionNov 6, 2023Decrease in Suction; Device Difficult to Setup or Prepare; Decrease in Suction; Device Difficult to Setup or Prepare

  IT WAS REPORTED THAT THERE WERE DIFFICULTIES IN INSERTING THE LIQUID OPTICAL INTERFACE (LOI) AND THERE WAS SUCTION LOSS. THROUGH FOLLOW-UP, WE LEARNED THAT THE SUCTION LOSS OCCURRED DURING THE LASER FIRING. THE PROCEDURE WAS TEMPORARILY ABORTED AND THEN RESUMED AS A STANDARD CATARACT SURGERY. NO ADDITIONAL INFORMATION WAS RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18076423 ↗
• MalfunctionJul 28, 2023Decrease in Suction; Decrease in Suction

  THIS REPORT SUMMARIZES 27 MALFUNCTION EVENTS. THE EVENT WAS RELATED TO SUCTION LOSS DURING LASER FIRING. THERE WERE NO PATIENT INJURIES REPORTED ASSOCIATED TO THE EVENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17420806 ↗
• MalfunctionMay 26, 2023Decrease in Suction; Decrease in Suction

  IT WAS REPORTED THAT A SUCTION LOSS DURING LASER TREATMENT OCCURRED USING THE LIQUID OPTICS INTERFACE (LOI). NO PATIENT INJURY OR SURGICAL INTERVENTION WAS NEEDED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17011742 ↗