ELITA EL2022Recalls & reported problems

Summary

The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 05050474738553), received between May 1, 2023 and Sep 28, 2026 — classified as 14 injuries, 17 malfunctions.

The most frequently reported specific device problem is “Decrease in Suction” (10 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 31 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2026Computer Software Problem

  It was reported that a system error occurred during surgery. No further information available.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50917794 ↗
• MalfunctionMar 9, 2026Decrease in Suction

  IT WAS REPORTED BY THE CUSTOMER USING THE ELITA SYSTEM THAT A POTENTIAL UNDETECTED SUCTION LOSS OCCURRED DURING AN ELITA FLAP PROCEDURE. AS A RESULT, THE FLAP WAS CUT INTO TWO LAYERS, BUT NO ERROR CODE WAS DISPLAYED. THE PATIENT FULLY RECOVERED FOLLOWING THE EVENT, AND NO DELAY IN THE PROCEDURE OR ADDITIONAL MEDICAL ATTENTION BEYOND STANDARD CARE WAS REQUIRED. NO FURTHER INFORMATION IS REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24546668 ↗
• InjuryFeb 25, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A FLAP PROCEDURE ON 29 JANUARY. ON THE FIRST POSTOPERATIVE DAY, A SLIGHT PERIPHERAL HAZE WAS NOTED IN THE OPERATED EYE, NOT AFFECTING THE PUPILLARY AREA. MEDICATION WAS PRESCRIBED AND FOLLOW-UP WAS PLANNED. ADDITIONAL INFORMATION INDICATED THAT THE HAZE HAD RESOLVED WITHIN 15 DAYS AFTER MEDICATION. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Corneal Clouding/Hazing

  MAUDE report 24443691 ↗
• MalfunctionNov 19, 2025Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE LASER STOPPED MID PATIENT TREATMENT WITH THE LASER ERROR 33-01-01. THROUGH FOLLOW-UP WE LEARNED THAT WHEN THE MACHINE STOPPED DURING THE TREATMENT AT THE FIRST TIME, THE SURGEON UNDOCKED THE PATIENT AND TRIED TO REPEAT THE TREATMENT ON THE SAME SESSION, BUT THE LASER STOPPED AGAIN AND THE PATIENT WAS STUCK, SO THEY HAD TO LIFT THE FLOATING OPTIC HEAD MANUALLY TO RELEASE THE PATIENT. THE SURGEON HASN`T TRIED TO LIFT THE FLAP AND WAITING SOME TIME BEFORE GOING FOR A PHOTOREFRACTIVE KERATECTOMY (PRK) OR A FEMTO LASIK AGAIN. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23598961 ↗
• MalfunctionNov 3, 2025Decrease in Suction; Decrease in Suction

  IT WAS REPORTED THAT THERE WAS A VACUUM LOSS DURING TREATMENT WITH ONE EYE (FIRST EYE TREATED SUCCESSFULLY) OF FIRST PATIENT WHICH WAS TREATED WITH PHOTOREFRACTIVE KERATECTOMY (PRK) ON (B)(6) WITH 1¿ST POST-OP VISUAL ACUITY (VA) 0.6- AND 10-DAYS LATER VA WAS 1.0. RIGHT NOW, PATIENT HAS VA 1.0 ON BOTH EYES. NO FURTHER INFORMATION WAS PROVIDED. THIS REPORT IS AGAINST THE ELITA SYSTEM. A SEPARATE REPORT WILL BE FILED AGAINST THE PATIENT INTERFACE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23452766 ↗
• InjuryJun 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A FLAP TREATMENT USING THE ELITA, THE SURGEON OBSERVED THAT WHILE PERFORMING THE PATIENT'S SECOND EYE, THE FLAP WAS VERY THIN AND THERE WAS A HOLE IN THE MIDDLE OF THE FLAP. FLAP THICKNESS WAS 110 MICRONS, BUT SURGEON REPORTED THAT PRACTICALLY IT FELT MUCH THINNER. THE PATIENT WAS TEMPORARILY IMPAIRED, NO MEDICAL INTERVENTIONS WERE MENTIONED. THROUGH FOLLOW-UP WE LEARNED THAT THE MENTIONED HOLE MEANT PERFORATION IN THE CORNEA. NO ISSUES WERE OBSERVED WITH THE PATIENT INTERFACE USED. THE DIRECTIONS FOR USE OF THE DEVICE WERE FOLLOWED. NO FURTHER INFORMATION WAS PROVIDED.

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

  MAUDE report 22123501 ↗
• MalfunctionMay 22, 2025Decrease in Suction; Mechanical Problem; Decrease in Suction; Mechanical Problem

  IT WAS REPORTED THAT SUCTION LOSS OCCURRED DURING FLAP TREATMENT IN THE PATIENT'S LEFT EYE (OS). BECAUSE OF THIS, THE TREATMENT RESULTED IN AN INCOMPLETE FLAP. THE DOCKING DID NOT APPEAR TO BE WELL CENTERED. NO ADDITIONAL INFORMATION WAS RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22070807 ↗
• MalfunctionMay 14, 2025Decrease in Suction; Appropriate Device Problem Term/Code Not Available; Decrease in Suction; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING A PROCEDURE, SUCTION LOSS OCCURRED ON THE PATIENT'S LEFT EYE (OS) WHILE USING THE ELITA SYSTEM. THE SURGEON NOTED THAT THE SYSTEM DID NOT PROVIDE ANY NOTIFICATION OF THE SUCTION LOSS DURING THE LASER FIRING. AS A RESULT, THE TREATMENT CONTINUED UNTIL COMPLETION, BUT THE SURGEON WAS UNABLE TO LIFT THE FLAP OR LOCATE THE SIDE CUT. CONSEQUENTLY, THE TREATMENT FOR THIS EYE WAS CONVERTED FROM LASIK TO PHOTOREFRACTIVE KERATECTOMY (PRK). THE CUSTOMER HIGHLIGHTED THE NEED FOR THE ELITA SYSTEM TO HAVE THE CAPABILITY TO MONITOR A LIVE IMAGE OF THE EYE DURING TREATMENT AND EXPRESSED CONCERN REGARDING THE LACK OF NOTIFICATIONS FOR SUCTION LOSS. NO ADDITIONAL INFORMATION WAS RECEIVED. THIS REPORT IS FOR ELITA. A SEPARATE REPORT IS BEING SUBMITTED FOR THE PATIENT INTERFACE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22020359 ↗
• InjuryApr 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT SINCE THE INSTALLATION OF THE ELITA DEVICE, THE SURGEON HAS OBSERVED A SLIGHT OCCURRENCE OF DIFFUSE LAMELLAR KERATITIS (DLK) IN NEARLY ALL PATIENTS TREATED WITH ELITA FLAPS, DESPITE ACHIEVING GOOD VISUAL OUTCOMES. THROUGH FOLLOW-UP, WE LEARNED THAT THE DOCTOR DID NOT CONFIRM THE EXACT NUMBER OF PATIENTS AFFECTED BY DLK OR THE DATE. NO MEDICAL OR SURGICAL INTERVENTIONS WERE REPORTED, AND NO ADDITIONAL INFORMATION WAS RECEIVED.

  Patient problems: Keratitis

  MAUDE report 21936445 ↗
• MalfunctionMar 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE CUSTOMER THAT DURING A SURGERY INVOLVING THE LASER ON THE RIGHT EYE OF A PATIENT, THE SURGEON PROGRAMMED A DEPTH OF 110 MICRONS. THE SURGERY PROCEEDED WELL UNTIL THE SURGEON LIFTED THE FLAP, WHICH WAS FOUND TO BE IN TWO PARTS, INDICATING THAT THE FLAP WAS THINNER THAN EXPECTED. AS A RESULT, THE PATIENT WAS INJURED. NO FURTHER DETAIL WAS PROVIDED.

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

  MAUDE report 21654441 ↗
• MalfunctionJan 14, 2025Decrease in Suction; Appropriate Device Problem Term/Code Not Available; Decrease in Suction; Appropriate Device Problem Term/Code Not Available

  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 21154547 ↗
• MalfunctionJan 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PHYSICIAN NOTICED AN ISSUE WITH ¿FIRST TEARED FLAP'. EYE AFFECTED WAS LEFT EYE (OS). THE RIGHT EYE (OD) WAS DONE WITHOUT ANY ISSUE. REPORTEDLY ON THE VIDEO IT WAS CLEARLY SEEN THAT THE FLAP WAS LIFTED ALREADY BUT THE PART AT 1 O¿CLOCK WAS TORN. PATIENT WAS TREATED AND FLAP CLOSED, A BANDAGE CONTACT LENS WAS APPLIED. THE TERRITORY MANAGER (TM) WAS TOLD BY THE SYSTEM OPERATOR, THAT THEY DID 1 MORE ATTEMPT FOR DOCKING, COULD NOT SUCCEED AND IN THE SECOND ATTEMPT, WHERE PATIENT INTERFACE (PI) WAS CHANGED, THIS ISSUE HAPPENED. ON THE IMAGE ON THE PATIENT REPORT, IT WAS CLEARLY SEEN, SOMETHING IN BETWEEN THE EYE AND PI GLASS. SYSTEM OPERATOR TOLD THE TM, THEY WARNED THE DOCTOR, BUT HE CONTINUED, PROBABLY FOUND IT NEGLIGIBLE. PATIENT'S DAILY ACTIVITIES ARE NOT AFFECTED. THROUGH FOLLOW-UP WE LEARNED THAT THE PATIENT¿S CONDITION AND OUTCOMES ARE POSITIVE. THE LOT NUMBER OF THE PI IS UNKNOWN AND IT WAS DISCARDED AFTER USE. THE PHYSICIAN SUSPECTED, THAT THE ISSUE CAME FROM ELITA. OS: SPH:+0.50 CYL: -1.00 AXIS: 160. NO FURTHER INFORMATION WAS PROVIDED. NOTE: A SEPARATE REPORT WILL BE SUBMITTED FOR THE 2ND PATIENT INTERFACE USED.

  Patient problems: Eye Injury

  MAUDE report 21114091 ↗
• InjuryNov 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SURGEON FOUND SOME PATIENTS HAVE GOOD VISUAL ACUITY (VA) BUT COMPLAIN OF DOUBLE VISION AND BLURRY VISION AFTER THE PROCEDURE WITH THE ELITA FEMTOSECOND LASER. A TOTAL OF 4 PATIENTS WERE INVOLVED. THIS COMPLAINT WAS DOCUMENTED FOR PATIENT 4, A MALE PATIENT. THE CORNEAL TOPOGRAPHY REVEALED A CENTRAL ISLAND. THE DIRECTIONS FOR USE WERE FOLLOWED. THE PATIENT STATUS WAS TEMPORARILY IMPAIRED. IT IS UNKNOWN WHETHER DAILY ACTIVITIES WERE SIGNIFICANTLY AFFECTED. THE BEST CORRECTED VISUAL ACUITY (BSCVA) PRE-OPERATIVE WAS 6/6. THE BSCVA POST-OPERATIVE WAS 6/6. IT IS UNKNOWN WHETHER THE END-USER SEEKS ANY MEDICAL ATTENTION. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Blurred Vision; Visual Impairment

  MAUDE report 20765919 ↗
• InjuryNov 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SURGEON FOUND SOME PATIENTS HAVE GOOD VISUAL ACUITY (VA) BUT COMPLAIN OF DOUBLE VISION AND BLURRY VISION AFTER THE PROCEDURE WITH THE ELITA FEMTOSECOND LASER. A TOTAL OF 4 PATIENTS WERE INVOLVED. THIS COMPLAINT WAS DOCUMENTED FOR PATIENT-3, A FEMALE PATIENT. THE CORNEAL TOPOGRAPHY REVEALED A CENTRAL ISLAND. THE DIRECTIONS FOR USE WERE FOLLOWED. THE PATIENT STATUS WAS TEMPORARILY IMPAIRED. IT IS UNKNOWN WHETHER DAILY ACTIVITIES WERE SIGNIFICANTLY AFFECTED. THE BEST CORRECTED VISUAL ACUITY (BSCVA) PRE-OPERATIVE WAS 6/6. THE BSCVA POST-OPERATIVE WAS 6/6. IT IS UNKNOWN WHETHER THE END-USER SEEKS ANY MEDICAL ATTENTION. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Blurred Vision; Visual Impairment

  MAUDE report 20765014 ↗
• InjuryNov 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SURGEON FOUND SOME PATIENTS HAVE GOOD VISUAL ACUITY (VA) BUT COMPLAIN OF DOUBLE VISION AND BLURRY VISION AFTER THE PROCEDURE WITH THE ELITA FEMTOSECOND LASER. A TOTAL OF 4 PATIENTS WERE INVOLVED. THIS COMPLAINT WAS DOCUMENTED FOR PATIENT-2, A MALE PATIENT. THE CORNEAL TOPOGRAPHY REVEALED A CENTRAL ISLAND. THE DIRECTIONS FOR USE WERE FOLLOWED. THE PATIENT STATUS WAS TEMPORARILY IMPAIRED. IT IS UNKNOWN WHETHER DAILY ACTIVITIES WERE SIGNIFICANTLY AFFECTED. THE BEST CORRECTED VISUAL ACUITY (BSCVA) PRE-OPERATIVE WAS 6/6. THE BSCVA POST-OPERATIVE WAS 6/6. IT IS UNKNOWN WHETHER THE END-USER SEEKS ANY MEDICAL ATTENTION. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Blurred Vision; Visual Impairment

  MAUDE report 20762249 ↗
• InjuryNov 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SURGEON FOUND SOME PATIENTS HAVE GOOD VISUAL ACUITY (VA) BUT COMPLAIN OF DOUBLE VISION AND BLURRY VISION AFTER THE PROCEDURE WITH THE ELITA FEMTOSECOND LASER. A TOTAL OF 4 PATIENTS WERE INVOLVED. THIS COMPLAINT WAS DOCUMENTED FOR PATIENT-1, A FEMALE PATIENT. THE CORNEAL TOPOGRAPHY REVEALED A CENTRAL ISLAND. THE DIRECTIONS FOR USE WERE FOLLOWED. THE PATIENT STATUS WAS TEMPORARILY IMPAIRED. IT IS UNKNOWN WHETHER DAILY ACTIVITIES WERE SIGNIFICANTLY AFFECTED. THE BEST CORRECTED VISUAL ACUITY (BSCVA) PRE-OPERATIVE WAS 6/6. THE BSCVA POST-OPERATIVE WAS 6/6. IT IS UNKNOWN WHETHER THE END-USER SEEKS ANY MEDICAL ATTENTION. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Blurred Vision; Visual Impairment

  MAUDE report 20636455 ↗
• InjuryOct 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER ONE MONTH POST-OP, THE PATIENT WAS HAVING CORNEA HAZE WITH FOGGY VISION AND LOW CONTRAST VISUAL ACUITY (VA) IN WHITE BACKGROUND. THE PATIENT'S PRE-OP BEST CORRECTED VISUAL ACUITY (BCVA) WAS -3.75 D (6/6) AND THE PRESCRIBED PLAN WAS -4.5 D FOR THE LEFT (OS) EYE. THERE WAS NO PATIENT INJURY. THE DIRECTIONS FOR USE WERE FOLLOWED. THE PATIENT WAS PRESCRIBED ARTIFICIAL TEARS, STEROIDS, NON-STEROIDAL ANTI-INFLAMMATORY DRUGS (NSAIDS), AND BETAMETHASONE SODIUM PHOSPHATE NEOMYCIN (SULFATE). NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Blurred Vision; Corneal Clouding/Hazing

  MAUDE report 20429856 ↗
• InjuryOct 11, 2024Computer Software Problem; Computer Software Problem

  IT WAS REPORTED THAT THERE WAS SYSTEM ERROR 33-11-02 (ENERGY ERROR) DURING SURGERY. ADDITIONAL INFORMATION STATED THAT PROCEDURAL TREATMENT WAS ABORTED DURING THE SURGERY AND TREATMENT WAS NOT COMPLETED ON SAME VISIT. PATIENT REQUIRED OTHER MEDICAL INTERVENTION AND HAD OTHER SURGERY NEXT DAY. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20425230 ↗
• 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 PATIENT INTERFACE. THIS REPORT PERTAINS TO ELITA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20371981 ↗
• MalfunctionSep 24, 2024Decrease in Suction; Decrease in Suction

  IT WAS REPORTED THAT THE SURGEON COMPLAINED ABOUT AN ISSUE WITH THE RIGHT EYE, WHERE THE SIDE CUT WAS NOT COMPLETE AND HE HAD TO LIFT IT WITH THE HELP OF A SURGICAL INSTRUMENT. ONCE THE FLAP WAS LIFTED, THE EXCIMER LASER PROCEDURE WAS COMPLETED. THE PATIENT IS DOING WELL AND THE RESULTS ARE GOOD. THE LEFT EYE OF THE SAME PATIENT WAS COMPLETED SUCCESSFULLY. THE PATIENT REPORT FROM ELITA INDICATED THAT THERE WAS VACUUM LOSS, AND NO ERROR MESSAGE OR WARNING ABOUT THIS ISSUE WAS PROVIDED. NO FURTHER INFORMATION WAS PROVIDED. A SEPARATE REPORT IS BEING SUBMITTED FOR THE PATIENT INTERFACE(PI) INVOLVED. THIS REPORT IS FOR THE ELITA LASER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20291887 ↗
• InjurySep 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE ELITA FLAP PROCEDURE, IN THE RIGHT EYE OF THE PATIENT, A SMALL EYELASH CAME IN THE BED AREA. WHILE LIFTING THE FLAP, THE FLAP WAS TORN AT ONE PART IN THE MIDDLE. THE SURGEON COMPLETED THE PROCEDURE AND PUT THE FLAP BACK PROPERLY. A BANDAGE CONTACT LENS (BCL) WAS USED. UPON FOLLOW-UP, IT WAS REPORTED THAT THERE WAS NO ISSUE WITH THE DEVICE. THE EYELASH CAME IN THE FIRE AREA, WHICH WENT UNNOTICED. THE PATIENT HAS MODERATE HAZE AND BLURRY VISION WITH POST-OP VISION 6/9. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Blurred Vision; Eye Injury

  MAUDE report 20291231 ↗
• MalfunctionJul 11, 2024Misfire; Misfire

  IT WAS REPORTED THAT THE SURGEON NOTICED THAT THERE WAS A MISFIRED FLAP IN THE RIGHT EYE (OD) DURING THE ELITA LASER FLAP PROCEDURE. AS PER THE SURGEON, THE PATIENT WAS VERY COOPERATIVE, AND THE VACUUM WAS ON THROUGHOUT THE PROCEDURE. THERE WAS NO PATIENT INJURY. THE SURGEON HAD TO REDO THE FLAP PROCEDURE AGAIN USING A NEW PATIENT INTERFACE (PI) TO SUCCESSFULLY COMPLETE THE SURGERY. THE PROCEDURE WAS COMPLETED ON THE SAME DAY. THE PATIENT IS DOING FINE AS PER THE POST-OP DATA INFORMATION FROM THE HOSPITAL. BUT THE SURGEON IS SUSPECTING THE PI QUALITY, AS A SIMILAR KIND OF MISFIRED FLAP HAPPENED AT THEIR HOSPITAL. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19721823 ↗
• InjuryMay 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS TRACES OF DLK IN BOTH EYES OF THE PATIENT. THERE WAS MAXIDEX AS POST-OP CARE GIVEN TO THE PATIENT. FROM THE FLAP CASE, THE RIGHT EYE WAS 6/7.5, LEFT EYE WAS 6/7.5 AND BOTH EYES WAS 6/6. THERE WAS NO DELAY IN TREATMENT OR OTHER INTERVENTIONS PERFORMED.

  Patient problems: Keratitis

  MAUDE report 19343335 ↗
• MalfunctionApr 29, 2024Decrease in Suction; Decrease in Suction

  IT WAS REPORTED THAT DURING LASER FIRE WITH AN ELITA LASER, SUCTION LOSS OCCURRED WITH FLAP DIFFICULT TO LIFT. NO FURTHER DETAIL WAS PROVIDED.

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

  MAUDE report 19209405 ↗
• MalfunctionApr 24, 2024Decrease in Suction; Decrease in Suction

  IT WAS REPORTED THAT A WHISTLING SOUND RESEMBLING OF LOSS OF SUCTION OCCURRED WITHOUT ANY ERROR MESSAGE, THE FLAP APPEARED THINNER THAN INTENDED AFTER LIFTING. NO FURTHER DETAIL WAS PROVIDED.

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

  MAUDE report 19177568 ↗