INTRALASE TECHNOLOGY PI 0155-1825Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 05050474655690), received between Aug 4, 2023 and Nov 19, 2025 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Decrease in Suction” (5 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 19, 2025Contamination; Contamination

  IT WAS REPORTED THERE WAS PRESENCE OF HAIR ON THE PATIENT INTERFACE. IT WAS UNKNOWN IF THERE WAS PATIENT INVOLVEMENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23600252 ↗
• MalfunctionOct 27, 2025Decrease in Suction; Device Difficult to Setup or Prepare; Decrease in Suction; Device Difficult to Setup or Prepare

  IT WAS REPORTED THAT SUCTION WAS LOSS AFTER LASER FIRE. DOCTOR MENTIONED THAT SUCTION RING WAS TOO BIG FOR PATIENT EYE. LASER WAS COMPLETED. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23392768 ↗
• MalfunctionAug 29, 2025Computer Software Problem; Contamination; Computer Software Problem; Contamination

  IT WAS REPORTED BY THE CUSTOMER THAT DURING THE USE OF THE ELITA® TWO-PIECE PATIENT INTERFACE SYSTEM ON (B)(6) 2025, THE PI (PATIENT INTERFACE) SCAN FAILED AFTER THE CONE WAS INSTALLED. THE NURSE CHECKED THE CONE AND FOUND THAT THE INNER CONE, THE CONTACT LENS, HAD WATER/OIL STAINS. THEY SUSPECT THERE WAS A LEAK BETWEEN THE CONTACT LENS AND THE SILICONE SEALING JUNCTION IN THE FIRST PI CONE, AND WATER/OIL STAINS WERE LEFT ON THE LASER HEAD, LEADING TO CONTAMINATION OF THE PI CONE. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22923276 ↗
• MalfunctionJan 14, 2025Decrease in Suction; Decrease in Suction

  IT WAS REPORTED THAT ON (B)(6) 2024, THE PHYSICIAN PERFORMED HIS FIRST ELITA FLAP PROCEDURE. AFTER TWO UNSUCCESSFUL ATTEMPTS TO DOCK THE RIGHT EYE (OD), THE SURGEON DECIDED TO PROCEED WITH THE LEFT EYE (OS). THE FIRST ATTEMPT WITH THE LEFT EYE SUCCESSFULLY ACHIEVED APPLANATION AND COMPLETE DOCKING. HOWEVER, THE FLAP SIZE WAS REDUCED TO 8.5 MM, BUT THE SURGEON CHOSE TO CONTINUE WITH THE PROCEDURE. THE PATIENT¿S REPORT IMAGE CLEARLY INDICATED THAT PRIOR TO PRESSING THE FOOTSWITCH TO ENGAGE THE LASER, BOTH THE EYE AND FLAP TEMPLATE WERE PROPERLY CENTERED. HOWEVER, IMMEDIATELY FOLLOWING THE PROCEDURE, THE IMAGE SHOWED SIGNIFICANT DECENTRATION OF THE EYE, WITH THE FLAP PARTIALLY CREATED ON THE CORNEA AND PARTIALLY ON THE SCLERA. AFTER A 30-MINUTE WAIT, HE TREATED THE PATIENT WITH TRANSPRK, AS THE PATIENT REQUESTED SAME-DAY TREATMENT. THE SURGEON ALSO REQUESTED THAT NO FURTHER TREATMENTS BE CONDUCTED UNTIL A THOROUGH SYSTEM CHECK WAS COMPLETED TO INVESTIGATE THE ISSUE DURING THE PROCEDURE. THE PATIENT¿S DAILY ACTIVITIES WERE NOT SIGNIFICANTLY AFFECTED. THROUGH FOLLOW-UP WE LEARNED THAT THE SURGEON EXPRESSED DISSATISFACTION WITH THE LACK OF A WARNING ABOUT THE VACUUM LOSS AND NOTED THAT T

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 21154554 ↗
• MalfunctionOct 4, 2024Decrease in Suction; Decrease in Suction

  IT WAS REPORTED THAT THERE WAS AN ISSUE WITH THE RIGHT EYE; THE SIDE CUT WAS INCOMPLETE. THE SURGEON DID NOT ATTEMPT TO LIFT THE FLAP AND DECIDED TO REDO IT AT A LATER STAGE. THE LEFT EYE WAS SUCCESSFULLY TREATED. THE SURGEON REVIEWED A PICTURE FROM THE PATIENT REPORT, WHICH CLEARLY SHOWED A VACUUM LOSS. THE SURGEON STATED THAT THERE WAS NO ERROR MESSAGE OR WARNING ABOUT THIS. DAILY ACTIVITIES WERE NOT SIGNIFICANTLY AFFECTED. THE DOCTOR BELIEVES THE ISSUE WAS DUE TO PATIENT MOVEMENT. NO FURTHER INFORMATION WAS PROVIDED. A SEPARATE REPORT IS BEING SUBMITTED FOR THE ELITA. THIS REPORT PERTAINS TO THE PATIENT INTERFACE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20373108 ↗
• MalfunctionAug 22, 2024Decrease in Suction; Decrease in Suction

  IT WAS REPORTED THAT ON THE LEFT EYE AND ON THE SECOND ATTEMPT DOCTOR OBTAINED ENOUGH MENISCUS AND CONTINUED WITH FLAP CREATION. AFTER LASER WAS COMPLETED, ON ELITA SCREEN CUSTOMER RECOGNIZED THAT THERE WAS A SUCTION LOSS. MENISCUS WAS WAY SMALLER AND FLAP BED WAS COMPLETED. SUCTION LOSS HAPPENED MOST PROBABLY DURING SIDE CUT. DOCTOR TRIED TO OPEN THE SIDE CUT CLOSE TO HINGE BUT DID NOT PROCEED SINCE HE CLEARLY SAW IT WAS INCOMPLETE. THE DOCTOR DECIDED TO APPLY CONTACT LENS AND WAIT TILL PATIENT RECOVERS AND PLAN THE SURGERY ON ANOTHER DATE. HE WILL CHECK THE PATIENT REFRACTION TO BE STABLE, DO ANTERIOR OCT TO CHECK THE FLAP BEFORE PROCEEDING WITH THE NEXT TREATMENT. PATIENT DAILY ACTIVITIES ARE NOT SIGNIFICANTLY AFFECTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20042625 ↗
• MalfunctionMar 28, 2024Contamination; Contamination

  IT WAS REPORTED THAT A FIBER WAS FOUND AFTER THE PATIENT'S CORNEA WAS APPLANATED AND LOCKED WITH THE ELITA SYSTEM. THE PATIENT'S CORNEA WAS CONTACTED WITH CONE GLASS. 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 18998536 ↗
• MalfunctionDec 26, 2023Contamination; Contamination

  IT WAS REPORTED THAT THERE WAS DEBRIS ON THE PATIENT INTERFACE WITH PATIENT CONTACT. NO PATIENT INJURY AND/OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18395666 ↗
• MalfunctionAug 4, 2023Decrease in Suction; Mechanical Problem; Decrease in Suction; Mechanical Problem

  IT WAS REPORTED THAT THE PHYSICIAN HAD DIFFICULTIES DOCKING WITH THE LEFT EYE (OS) OF THE PATIENT. ACCOUNT STATED THAT THESE DID NOT SEEM TO BE RELATED TO THE SURGEONS TECHNIQUE OR DOCKING. HE WAS CENTERED AND NOT TILTED. WHENEVER HE MADE CONTACT WITH THE CORNEA, THE SUCTION RING SEEMED TO ¿LOSE ALL SUCTION¿. THE PHYSICIAN WAS ABLE TO FINALLY GET SUCTION AND PROCEED WITH THE TREATMENT. SUCTION WAS LOST DURING THE PROCEDURE. NO ERROR MESSAGE FROM THE LASER WAS OBSERVED. THE PATIENT FLAP WAS INCOMPLETE AS A RESULT AND WAS NOT LIFTED. THE PATIENT WAS TREATED THAT SAME DAY WITH THE IFS TO CREATE A SIDE CUT ONLY CUT. ACCOUNT STATED DIRECTIONS FOR USE (DFU) WERE FOLLOWED, THERE WAS A DELAY AND THE DAILY ACTIVITIES WERE NOT AFFECTED. NO ISSUES REPORTED DURING IFS/EXCIMER LASER SURGERY. BEST CORRECT VISUAL ACUITY RIGHT EYE 6/5 ; LEFT EYE 6/5 AT ONE DAY POST OP VISIT. NO FURTHER INFORMATION WAS PROVIDED. A SEPARATE REPORT WILL BE SUBMITTED FOR THE ELITA LASER SYSTEM.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17462982 ↗