FS DISPOSABLE INTERFACE 590106ANRecalls & reported problems

Summary

The FDA's MAUDE database contains 4,174 adverse event reports that list this exact device (DI 15050474534688), received between Aug 29, 2016 and Sep 30, 2026 — classified as 351 injuries, 3,823 malfunctions.

The most frequently reported specific device problem is “Suction Problem” (2,827 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 4,174 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Contamination

  The customer reported their patient interface with debris in contact with the patient, and no patient injury was reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50942924 ↗
• MalfunctionSep 24, 2026Decrease in Suction

  It was reported by the customer that the patient interface (PI) had Suction loss during the raster pattern and the stromal bed showed a divet after the lift. There was no patient injury or surgical intervention reported. No further information was provided.NOTE: This report is against the Patient Interface. A separate report will be submitted for the FS Laser.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50884021 ↗
• InjuryMay 29, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER THE PATIENT WAS TREATED WITH THE IFS FEMTOSECOND LASER ON (B)(6) 2026, THE PATIENT EXPERIENCED STRIAE IN THE RIGHT EYE (OD). THE PATIENT HAD TO RETURN FOR FLAP LIFT, WASH AND RINSE ON (B)(6) 2026. NO FURTHER INFORMATION WAS PROVIDED. PACHYMETRY OD/LEFT EYE (OS) = 524/519. PREOP BEST CORRECTED VISUAL ACUITY (BCVA) OD = 6/5. PREOP BCVA OS = 6/5. PREOP REFRACTION OD = S -1.75 C-1.0 S 170. PREOP REFRACTION OS = S-1.50 C-0.75 A 160. 1 DAY POSTOP UNCORRECTED VISUAL ACUITY (UCVA) OD = 6/5. 1 DAY POSTOP UCVA OS = 6/5. 1 POST FLAP LIFT UCVA OD = 6/5. 1 POST FLAP LIFT UCVA OS = 6/5. NOTE: THIS REPORT IS FOR THE PATIENT INTERFACE. A SEPARATE REPORT IS BEING SUBMITTED FOR THE IFS FEMTOSECOND LASER.

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

  MAUDE report 25332492 ↗
• InjuryMay 29, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER THE PATIENT WAS TREATED WITH THE IFS FEMTOSECOND LASER ON (B)(6) 2026, THE PATIENT EXPERIENCED STRIAE IN THE RIGHT EYE (OD). THE PATIENT HAD TO RETURN FOR FLAP LIFT, WASH AND RINSE ON THE (B)(6) 2026. NO FURTHER INFORMATION WAS PROVIDED. PACHYMETRY: OD/LEFT EYE (OS) = 548/544. PREOP BEST CORRECTED VISUAL ACUITY (BCVA) OD = 6/5. PREOP BCVA OS = 6/5. PREOP REFRACTION OD = S -6.5 C-0.75 A 155/. PREOP REFRACTION OS = S -6.5 C-0.75 A 155/S-6.25 C-0.50 A 20. 1 DAY POSTOP UNCORRECTED VISUAL ACUITY (UCVA) OD = 6/20. 1 DAY POSTOP UCVA OS = 6/7.5. 1 POST FLAP LIFT UCVA OD = 6/6. 1 POST FLAP LIFT UCVA OS = 6/5. NOTE: THIS REPORT IS AGAINST THE PATIENT INTERFACE. A SEPARATE REPORT IS BEING FILED AGAINST THE IFS FEMTOSECOND LASER.

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

  MAUDE report 25332247 ↗
• InjuryMay 29, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER THE PATIENT WAS TREATED WITH THE IFS FEMTOSECOND LASER ON (B)(6) 2026, THE PATIENT EXPERIENCED STRIAE IN THE LEFT EYE (OS). THE PATIENT HAD TO RETURN TO A DIFFERENT CLINIC FOR FLAP LIFT, WASH AND RINSE ON THE (B)(6) 2026. NO FURTHER INFORMATION WAS PROVIDED. PACHYMETRY: RIGHT EYE (OD)/OS = 519/516. PREOP BEST CORRECTED VISUAL ACUITY (BCVA) OD = 6/5 . PREOP BCVA OS = 6/5. PREOP REFRACTION OD = S-1.75 C-0.25 A 40. PREOP REFRACTION OS = S-2.25 C-0.25 A 180. 1 DAY POSTOP UNCORRECTED VISUAL ACUITY (UCVA) OD = 6/6. 1 DAY POSTOP UCVA OS = 6.12. 1 POST FLAP LIFT UCVA OD = 6/12. 1 POST FLAP LIFT UCVA OS = 6/5. THIS REPORT IS FOR THE PATIENT INTERFACE. A SEPARATE REPORT IS BEING SUBMITTED FOR THE IFS FEMTOSECOND LASER.

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

  MAUDE report 25332140 ↗
• InjuryMay 29, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT FOLLOWING TREATMENT WITH THE IFS FEMTOSECOND LASER BETWEEN JANUARY AND MARCH 2026, ONE PATIENT EXPERIENCED STRIAE FLAP DISPLACEMENT IN ONE EYE. THE PATIENT HAD TO RETURN FOR FLAP LIFT, WASH AND RINSE. NO FURTHER INFORMATION WAS PROVIDED. NOTE: THIS REPORT IS FOR THE PATIENT INTERFACE. A SEPARATE REPORT IS BEING SUBMITTED FOR THE IFS FEMTOSECOND LASER.

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

  MAUDE report 25326756 ↗
• InjuryMay 29, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT FOLLOWING TREATMENT WITH THE IFS FEMTOSECOND LASER BETWEEN JULY AND DECEMBER 2023, ONE PATIENT EXPERIENCED STRIAE FLAP DISPLACEMENT IN ONE EYE. THE PATIENT HAD TO RETURN FOR FLAP LIFT, WASH AND RINSE. NO FURTHER INFORMATION WAS PROVIDED. THROUGH FOLLOW-UP, ADDITIONAL INFORMATION WAS OBTAINED; HOWEVER, IT IS UNCLEAR TO WHICH OF THE PATIENTS THIS INFORMATION PERTAINS. THEREFORE, THIS INFORMATION IS BEING INCLUDED IN ALL CORRESPONDING COMPLAINT FILES. ONE (1) PATIENT HAS LEFT EYE (OS) BEST CORRECTED VISUAL ACUITY (BCVA) PREOP 6/6 AND 6/7 POST FLAP LIFT. THE REST HAVE ACHIEVED UNCORRECTED VISUAL ACUITY (UCVA) POST FLAP LIFT 6/6 OR ABOVE. ONE WITH UCVA 6/7.5 AND BCVA OF 6/6. NO ONE LOST MORE THAN 2 LINES OF BCVA. THIS REPORT IS FOR THE PATIENT INTERFACE. A SEPARATE REPORT IS BEING SUBMITTED FOR THE IFS FEMTOSECOND LASER.

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

  MAUDE report 25326634 ↗
• InjuryMay 29, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT FOLLOWING TREATMENT WITH THE IFS FEMTOSECOND LASER BETWEEN (B)(6) 2024, A PATIENT EXPERIENCED STRIAE FLAP DISPLACEMENT IN ONE EYE. THE PATIENT HAD TO RETURN FOR FLAP LIFT, WASH AND RINSE. NO FURTHER INFORMATION WAS PROVIDED. THROUGH FOLLOW-UP, ADDITIONAL INFORMATION WAS OBTAINED; HOWEVER, IT IS UNCLEAR TO WHICH OF THE PATIENTS THIS INFORMATION PERTAINS. THEREFORE, THIS INFORMATION IS BEING INCLUDED IN ALL CORRESPONDING COMPLAINT FILES. ONE (1) PATIENT HAS LEFT EYE (OS) BEST CORRECTED VISUAL ACUITY (BCVA) PREOP 6/6 AND 6/7 POST FLAP LIFT. THE REST HAVE ACHIEVED UNCORRECTED VISUAL ACUITY (UCVA) POST FLAP LIFT 6/6 OR ABOVE. ONE WITH UCVA 6/7.5 AND BCVA OF 6/6. NO ONE LOST MORE THAN 2 LINES OF BCVA. NOTE THIS REPORT IS FOR THE PATIENT INTERFACE. A SEPARATE REPORT IS BEING SUBMITTED FOR THE IFS FEMTOSECOND LASER.

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

  MAUDE report 25326599 ↗
• InjuryMay 29, 2026Mechanical Problem

  IT WAS REPORTED THAT AFTER THE PATIENT WAS TREATED WITH THE IFS FEMTOSECOND LASER HAD TO RETURN TO THE CLINIC FOR FLAP LIFT, WASH AND RINSE. THE CLINIC REPORTED THE INTRODUCTION OF A NEW BATCH OF PATIENT INTERFACES (PI) WHICH HAD DOCKING DIFFERENCES. NO FURTHER INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION HAS BEEN REPORTED WITHOUT INFORMATION AS TO WHAT PATIENT IT RELATES TO. DUE TO THIS, THE BELOW HAS BEEN ADDED TO ALL RELEVANT COMPLAINT FILES TO ENSURE EVENT CAPTURED COMPLETELY. STRIAE FLAP DISPLACEMENT. THIS REPORT IS FOR THE IFS FEMTOSECOND LASER. A SEPARATE REPORT IS BEING SUBMITTED FOR THE PATIENT INTERFACE.

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

  MAUDE report 25326532 ↗
• MalfunctionMay 29, 2026Decrease in Suction; Device Difficult to Setup or Prepare

  IT WAS REPORTED THAT WHILE USING THE PATIENT INTERFACE (PI) THE SURGEON FOUND THE DEVICE TO BE VERY STIFF WHICH MADE PLACEMENT CHALLENGING. DUE TO THIS, THE DEVICE WOULD NOT MAINTAIN SUCTION SO WAS REPLACED WITH A BACK UP. THE SURGEON ALSO REPORTED THE REPLACEMENT DEVICE TO BE VERY STIFF. THERE WAS NO PATIENT INJURY AND THE PROCEDURE WAS COMPLETED WITHOUT FURTHER ISSUE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25326464 ↗
• InjuryMay 28, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT FOLLOWING TREATMENT WITH THE IFS FEMTOSECOND LASER BETWEEN (B)(6) 2025, FOUR PATIENTS EXPERIENCED STRIAE FLAP DISPLACEMENT IN UNKNOWN EYE. THE PATIENTS HAD TO RETURN FOR FLAP LIFT, WASH AND RINSE. NO FURTHER INFORMATION WAS PROVIDED. THROUGH FOLLOW-UP, ADDITIONAL INFORMATION WAS OBTAINED; HOWEVER, IT IS UNCLEAR TO WHICH OF THE PATIENTS THIS INFORMATION PERTAINS. THEREFORE, THIS INFORMATION IS BEING INCLUDED IN ALL CORRESPONDING COMPLAINT FILES. ONE (1) PATIENT HAS LEFT EYE (OS) BEST CORRECTED VISUAL ACUITY (BCVA) PREOP 6/6 AND 6/7 POST FLAP LIFT. THE REST HAVE ACHIEVED UNCORRECTED VISUAL ACUITY (UCVA) POST FLAP LIFT 6/6 OR ABOVE. ONE WITH UCVA 6/7.5 AND BCVA OF 6/6. NO ONE LOST MORE THAN 2 LINES OF BCVA. NOTE: THIS REPORT PERTAINS TO THE PATIENT INTERFACE FOR ONE OF THE FOUR PATIENTS. A SEPARATE REPORT IS BEING SUBMITTED FOR THE ASSOCIATED IFS FEMTOSECOND LASER. ADDITIONALLY, SEPARATE REPORTS ARE BEING SUBMITTED FOR THE PATIENT INTERFACE FOR THE REMAINING THREE PATIENTS, AS WELL AS THE IFS FEMTOSECOND LASER.

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

  MAUDE report 25325819 ↗
• InjuryMay 28, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT FOLLOWING TREATMENT WITH THE IFS FEMTOSECOND LASER BETWEEN (B)(6) 2025, FOUR PATIENTS EXPERIENCED STRIAE FLAP DISPLACEMENT IN UNKNOWN EYE. THE PATIENTS HAD TO RETURN FOR FLAP LIFT, WASH AND RINSE. NO FURTHER INFORMATION WAS PROVIDED. THROUGH FOLLOW-UP, ADDITIONAL INFORMATION WAS OBTAINED; HOWEVER, IT IS UNCLEAR TO WHICH OF THE PATIENTS THIS INFORMATION PERTAINS. THEREFORE, THIS INFORMATION IS BEING INCLUDED IN ALL CORRESPONDING COMPLAINT FILES. ONE (1) PATIENT HAS LEFT EYE (OS) BEST CORRECTED VISUAL ACUITY (BCVA) PREOP 6/6 AND 6/7 POST FLAP LIFT. THE REST HAVE ACHIEVED UNCORRECTED VISUAL ACUITY (UCVA) POST FLAP LIFT 6/6 OR ABOVE. ONE WITH UCVA 6/7.5 AND BCVA OF 6/6. NO ONE LOST MORE THAN 2 LINES OF BCVA. NOTE: THIS REPORT PERTAINS TO THE PATIENT INTERFACE FOR ONE OF THE FOUR PATIENTS. A SEPARATE REPORT IS BEING SUBMITTED FOR THE ASSOCIATED IFS FEMTOSECOND LASER. ADDITIONALLY, SEPARATE REPORTS ARE BEING SUBMITTED FOR THE PATIENT INTERFACE FOR THE REMAINING THREE PATIENTS, AS WELL AS THE IFS FEMTOSECOND LASER.

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

  MAUDE report 25325817 ↗
• InjuryMay 28, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT FOLLOWING TREATMENT WITH THE IFS FEMTOSECOND LASER BETWEEN (B)(6) 2025, FOUR PATIENTS EXPERIENCED STRIAE FLAP DISPLACEMENT IN UNKNOWN EYE. THE PATIENTS HAD TO RETURN FOR FLAP LIFT, WASH AND RINSE. NO FURTHER INFORMATION WAS PROVIDED. THROUGH FOLLOW-UP, ADDITIONAL INFORMATION WAS OBTAINED; HOWEVER, IT IS UNCLEAR TO WHICH OF THE PATIENTS THIS INFORMATION PERTAINS. THEREFORE, THIS INFORMATION IS BEING INCLUDED IN ALL CORRESPONDING COMPLAINT FILES. ONE (1) PATIENT HAS LEFT EYE (OS) BEST CORRECTED VISUAL ACUITY (BCVA) PREOP 6/6 AND 6/7 POST FLAP LIFT. THE REST HAVE ACHIEVED UNCORRECTED VISUAL ACUITY (UCVA) POST FLAP LIFT 6/6 OR ABOVE. ONE WITH UCVA 6/7.5 AND BCVA OF 6/6. NO ONE LOST MORE THAN 2 LINES OF BCVA. NOTE: THIS REPORT PERTAINS TO THE PATIENT INTERFACE FOR ONE OF THE FOUR PATIENTS. A SEPARATE REPORT IS BEING SUBMITTED FOR THE ASSOCIATED IFS FEMTOSECOND LASER. ADDITIONALLY, SEPARATE REPORTS ARE BEING SUBMITTED FOR THE PATIENT INTERFACE FOR THE REMAINING THREE PATIENTS, AS WELL AS THE IFS FEMTOSECOND LASER.

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

  MAUDE report 25325804 ↗
• InjuryMay 28, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT FOLLOWING TREATMENT WITH THE IFS FEMTOSECOND LASER BETWEEN (B)(6) AND (B)(6) 2025, FOUR PATIENTS EXPERIENCED STRIAE FLAP DISPLACEMENT IN UNKNOWN EYE. THE PATIENTS HAD TO RETURN FOR FLAP LIFT, WASH AND RINSE. NO FURTHER INFORMATION WAS PROVIDED. THROUGH FOLLOW-UP, ADDITIONAL INFORMATION WAS OBTAINED; HOWEVER, IT IS UNCLEAR TO WHICH OF THE PATIENTS THIS INFORMATION PERTAINS. THEREFORE, THIS INFORMATION IS BEING INCLUDED IN ALL CORRESPONDING COMPLAINT FILES. ONE (1) PATIENT HAS LEFT EYE (OS) BEST CORRECTED VISUAL ACUITY (BCVA) PREOP 6/6 AND 6/7 POST FLAP LIFT. THE REST HAVE ACHIEVED UNCORRECTED VISUAL ACUITY (UCVA) POST FLAP LIFT 6/6 OR ABOVE. ONE WITH UCVA 6/7.5 AND BCVA OF 6/6. NO ONE LOST MORE THAN 2 LINES OF BCVA. NOTE: THIS REPORT PERTAINS TO THE PATIENT INTERFACE FOR ONE OF THE FOUR PATIENTS. A SEPARATE REPORT IS BEING SUBMITTED FOR THE ASSOCIATED IFS FEMTOSECOND LASER. ADDITIONALLY, SEPARATE REPORTS ARE BEING SUBMITTED FOR THE PATIENT INTERFACE FOR THE REMAINING THREE PATIENTS, AS WELL AS THE IFS FEMTOSECOND LASER.

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

  MAUDE report 25325550 ↗
• InjuryMay 28, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT FOLLOWING TREATMENT WITH THE IFS FEMTOSECOND LASER BETWEEN (B)(6) 2025, SIX PATIENTS EXPERIENCED STRIAE FLAP DISPLACEMENT IN UNKNOWN EYE. THE PATIENTS HAD TO RETURN FOR FLAP LIFT, WASH AND RINSE. NO FURTHER INFORMATION WAS PROVIDED. THROUGH FOLLOW-UP, ADDITIONAL INFORMATION WAS OBTAINED; HOWEVER, IT IS UNCLEAR TO WHICH OF THE PATIENTS THIS INFORMATION PERTAINS. THEREFORE, THIS INFORMATION IS BEING INCLUDED IN ALL CORRESPONDING COMPLAINT FILES. ONE (1) PATIENT HAS LEFT EYE (OS) BEST CORRECTED VISUAL ACUITY (BCVA) PREOP 6/6 AND 6/7 POST FLAP LIFT. THE REST HAVE ACHIEVED UNCORRECTED VISUAL ACUITY (UCVA) POST FLAP LIFT 6/6 OR ABOVE. ONE WITH UCVA 6/7.5 AND BCVA OF 6/6. NO ONE LOST MORE THAN 2 LINES OF BCVA. NOTE: THIS REPORT PERTAINS TO THE PATIENT INTERFACE FOR ONE OF THE SIX PATIENTS. A SEPARATE REPORT IS BEING SUBMITTED FOR THE ASSOCIATED IFS FEMTOSECOND LASER. ADDITIONALLY, SEPARATE REPORTS ARE BEING SUBMITTED FOR THE PATIENT INTERFACE FOR THE REMAINING FIVE PATIENTS, AS WELL AS THE IFS FEMTOSECOND LASER.

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

  MAUDE report 25324330 ↗
• InjuryMay 28, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT FOLLOWING TREATMENT WITH THE IFS FEMTOSECOND LASER BETWEEN (B)(6) 2025, SIX PATIENTS EXPERIENCED STRIAE FLAP DISPLACEMENT IN UNKNOWN EYE. THE PATIENTS HAD TO RETURN FOR FLAP LIFT, WASH AND RINSE. NO FURTHER INFORMATION WAS PROVIDED. THROUGH FOLLOW-UP, ADDITIONAL INFORMATION WAS OBTAINED; HOWEVER, IT IS UNCLEAR TO WHICH OF THE PATIENTS THIS INFORMATION PERTAINS. THEREFORE, THIS INFORMATION IS BEING INCLUDED IN ALL CORRESPONDING COMPLAINT FILES. ONE (1) PATIENT HAS LEFT EYE (OS) BEST CORRECTED VISUAL ACUITY (BCVA) PREOP 6/6 AND 6/7 POST FLAP LIFT. THE REST HAVE ACHIEVED UNCORRECTED VISUAL ACUITY (UCVA) POST FLAP LIFT 6/6 OR ABOVE. ONE WITH UCVA 6/7.5 AND BCVA OF 6/6. NO ONE LOST MORE THAN 2 LINES OF BCVA. NOTE: THIS REPORT PERTAINS TO THE PATIENT INTERFACE FOR ONE OF THE SIX PATIENTS. A SEPARATE REPORT IS BEING SUBMITTED FOR THE ASSOCIATED IFS FEMTOSECOND LASER. ADDITIONALLY, SEPARATE REPORTS ARE BEING SUBMITTED FOR THE PATIENT INTERFACE FOR THE REMAINING FIVE PATIENTS, AS WELL AS THE IFS FEMTOSECOND LASER.

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

  MAUDE report 25324246 ↗
• InjuryMay 28, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT FOLLOWING TREATMENT WITH THE IFS FEMTOSECOND LASER BETWEEN (B)(6) AND (B)(6) 2025, SIX PATIENTS EXPERIENCED STRIAE FLAP DISPLACEMENT IN UNKNOWN EYE. THE PATIENTS HAD TO RETURN FOR FLAP LIFT, WASH AND RINSE. NO FURTHER INFORMATION WAS PROVIDED. THROUGH FOLLOW-UP, ADDITIONAL INFORMATION WAS OBTAINED; HOWEVER, IT IS UNCLEAR TO WHICH OF THE PATIENTS THIS INFORMATION PERTAINS. THEREFORE, THIS INFORMATION IS BEING INCLUDED IN ALL CORRESPONDING COMPLAINT FILES. ONE (1) PATIENT HAS LEFT EYE (OS) BEST CORRECTED VISUAL ACUITY (BCVA) PREOP 6/6 AND 6/7 POST FLAP LIFT. THE REST HAVE ACHIEVED UNCORRECTED VISUAL ACUITY (UCVA) POST FLAP LIFT 6/6 OR ABOVE. ONE WITH UCVA 6/7.5 AND BCVA OF 6/6. NO ONE LOST MORE THAN 2 LINES OF BCVA. NOTE: THIS REPORT PERTAINS TO THE PATIENT INTERFACE FOR ONE OF THE SIX PATIENTS. A SEPARATE REPORT IS BEING SUBMITTED FOR THE ASSOCIATED IFS FEMTOSECOND LASER. ADDITIONALLY, SEPARATE REPORTS ARE BEING SUBMITTED FOR THE PATIENT INTERFACE FOR THE REMAINING FIVE PATIENTS, AS WELL AS THE IFS FEMTOSECOND LASER.

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

  MAUDE report 25323816 ↗
• InjuryMay 28, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT FOLLOWING TREATMENT WITH THE IFS FEMTOSECOND LASER BETWEEN JANUARY AND JUNE 2025, SIX PATIENTS EXPERIENCED STRIAE FLAP DISPLACEMENT IN UNKNOWN EYE. THE PATIENTS HAD TO RETURN FOR FLAP LIFT, WASH AND RINSE. NO FURTHER INFORMATION WAS PROVIDED. THROUGH FOLLOW-UP, ADDITIONAL INFORMATION WAS OBTAINED; HOWEVER, IT IS UNCLEAR TO WHICH OF THE PATIENTS THIS INFORMATION PERTAINS. THEREFORE, THIS INFORMATION IS BEING INCLUDED IN ALL CORRESPONDING COMPLAINT FILES. ONE (1) PATIENT HAS LEFT EYE (OS) BEST CORRECTED VISUAL ACUITY (BCVA) PREOP 6/6 AND 6/7 POST FLAP LIFT. THE REST HAVE ACHIEVED UNCORRECTED VISUAL ACUITY (UCVA) POST FLAP LIFT 6/6 OR ABOVE. ONE WITH UCVA 6/7.5 AND BCVA OF 6/6. NO ONE LOST MORE THAN 2 LINES OF BCVA. NOTE: THIS REPORT PERTAINS TO THE PATIENT INTERFACE FOR ONE OF THE SIX PATIENTS. A SEPARATE REPORT IS BEING SUBMITTED FOR THE ASSOCIATED IFS FEMTOSECOND LASER. ADDITIONALLY, SEPARATE REPORTS ARE BEING SUBMITTED FOR THE PATIENT INTERFACE FOR THE REMAINING FIVE PATIENTS, AS WELL AS THE IFS FEMTOSECOND LASER.

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

  MAUDE report 25323720 ↗
• InjuryMay 28, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT FOLLOWING TREATMENT WITH THE IFS FEMTOSECOND LASER BETWEEN (B)(6) AND (B)(6) 2025, SIX PATIENTS EXPERIENCED STRIAE FLAP DISPLACEMENT IN UNKNOWN EYE. THE PATIENTS HAD TO RETURN FOR FLAP LIFT, WASH AND RINSE. NO FURTHER INFORMATION WAS PROVIDED. THROUGH FOLLOW-UP, ADDITIONAL INFORMATION WAS OBTAINED; HOWEVER, IT IS UNCLEAR TO WHICH OF THE PATIENTS THIS INFORMATION PERTAINS. THEREFORE, THIS INFORMATION IS BEING INCLUDED IN ALL CORRESPONDING COMPLAINT FILES. ONE (1) PATIENT HAS LEFT EYE (OS) BEST CORRECTED VISUAL ACUITY (BCVA) PREOP 6/6 AND 6/7 POST FLAP LIFT. THE REST HAVE ACHIEVED UNCORRECTED VISUAL ACUITY (UCVA) POST FLAP LIFT 6/6 OR ABOVE. ONE WITH UCVA 6/7.5 AND BCVA OF 6/6. NO ONE LOST MORE THAN 2 LINES OF BCVA. NOTE: THIS REPORT PERTAINS TO THE PATIENT INTERFACE FOR ONE OF THE SIX PATIENTS. A SEPARATE REPORT IS BEING SUBMITTED FOR THE ASSOCIATED IFS FEMTOSECOND LASER. ADDITIONALLY, SEPARATE REPORTS ARE BEING SUBMITTED FOR THE PATIENT INTERFACE FOR THE REMAINING FIVE PATIENTS, AS WELL AS THE IFS FEMTOSECOND LASER.

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

  MAUDE report 25323627 ↗
• InjuryMay 28, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT FOLLOWING TREATMENT WITH THE IFS FEMTOSECOND LASER BETWEEN (B)(6) AND (B)(6) 2025, SIX PATIENTS EXPERIENCED STRIAE FLAP DISPLACEMENT IN UNKNOWN EYE. THE PATIENTS HAD TO RETURN FOR FLAP LIFT, WASH AND RINSE. NO FURTHER INFORMATION WAS PROVIDED. THROUGH FOLLOW-UP, ADDITIONAL INFORMATION WAS OBTAINED; HOWEVER, IT IS UNCLEAR TO WHICH OF THE PATIENTS THIS INFORMATION PERTAINS. THEREFORE, THIS INFORMATION IS BEING INCLUDED IN ALL CORRESPONDING COMPLAINT FILES. ONE (1) PATIENT HAS LEFT EYE (OS) BEST CORRECTED VISUAL ACUITY (BCVA) PREOP 6/6 AND 6/7 POST FLAP LIFT. THE REST HAVE ACHIEVED UNCORRECTED VISUAL ACUITY (UCVA) POST FLAP LIFT 6/6 OR ABOVE. ONE WITH UCVA 6/7.5 AND BCVA OF 6/6. NO ONE LOST MORE THAN 2 LINES OF BCVA. NOTE: THIS REPORT PERTAINS TO THE PATIENT INTERFACE FOR ONE OF THE SIX PATIENTS. A SEPARATE REPORT IS BEING SUBMITTED FOR THE ASSOCIATED IFS FEMTOSECOND LASER. ADDITIONALLY, SEPARATE REPORTS ARE BEING SUBMITTED FOR THE PATIENT INTERFACE FOR THE REMAINING FIVE PATIENTS, AS WELL AS THE IFS FEMTOSECOND LASER.

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

  MAUDE report 25323502 ↗
• InjuryMay 28, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT FOLLOWING TREATMENT WITH THE IFS FEMTOSECOND LASER BETWEEN JANUARY AND JUNE 2023, THREE PATIENTS EXPERIENCED STRIAE FLAP DISPLACEMENT IN ONE EYE. THE PATIENTS HAD TO RETURN FOR FLAP LIFT, WASH AND RINSE. NO FURTHER INFORMATION WAS PROVIDED. THROUGH FOLLOW-UP, ADDITIONAL INFORMATION WAS OBTAINED; HOWEVER, IT IS UNCLEAR TO WHICH OF THE THREE PATIENTS THIS INFORMATION PERTAINS. THEREFORE, THIS INFORMATION IS BEING INCLUDED IN ALL CORRESPONDING COMPLAINT FILES. ONE (1) PATIENT HAS LEFT EYE (OS) BEST CORRECTED VISUAL ACUITY (BCVA) PREOP 6/6 AND 6/7 POST FLAP LIFT. THE REST HAVE ACHIEVED UNCORRECTED VISUAL ACUITY (UCVA) POST FLAP LIFT 6/6 OR ABOVE. ONE WITH UCVA 6/7.5 AND BCVA OF 6/6. NO ONE LOST MORE THAN 2 LINES OF BCVA. NOTE: THIS REPORT PERTAINS TO THE PATIENT INTERFACE FOR ONE OF THE THREE PATIENTS. A SEPARATE REPORT IS BEING SUBMITTED FOR THE ASSOCIATED IFS FEMTOSECOND LASER. ADDITIONALLY, SEPARATE REPORTS ARE BEING SUBMITTED FOR THE PATIENT INTERFACE FOR THE REMAINING TWO PATIENTS, AS WELL AS THE IFS FEMTOSECOND LASER.

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

  MAUDE report 25319837 ↗
• InjuryMay 28, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT FOLLOWING TREATMENT WITH THE IFS FEMTOSECOND LASER BETWEEN JANUARY AND JUNE 2023, THREE PATIENTS EXPERIENCED STRIAE FLAP DISPLACEMENT IN ONE EYE. THE PATIENTS HAD TO RETURN FOR FLAP LIFT, WASH AND RINSE. NO FURTHER INFORMATION WAS PROVIDED. THROUGH FOLLOW-UP, ADDITIONAL INFORMATION WAS OBTAINED; HOWEVER, IT IS UNCLEAR TO WHICH OF THE THREE PATIENTS THIS INFORMATION PERTAINS. THEREFORE, THIS INFORMATION IS BEING INCLUDED IN ALL CORRESPONDING COMPLAINT FILES. ONE (1) PATIENT HAS LEFT EYE (OS) BEST CORRECTED VISUAL ACUITY (BCVA) PREOP 6/6 AND 6/7 POST FLAP LIFT. THE REST HAVE ACHIEVED UNCORRECTED VISUAL ACUITY (UCVA) POST FLAP LIFT 6/6 OR ABOVE. ONE WITH UCVA 6/7.5 AND BCVA OF 6/6. NO ONE LOST MORE THAN 2 LINES OF BCVA. NOTE: THIS REPORT PERTAINS TO THE PATIENT INTERFACE FOR ONE OF THE THREE PATIENTS. A SEPARATE REPORT IS BEING SUBMITTED FOR THE ASSOCIATED IFS FEMTOSECOND LASER. ADDITIONALLY, SEPARATE REPORTS ARE BEING SUBMITTED FOR THE PATIENT INTERFACE FOR THE REMAINING TWO PATIENTS, AS WELL AS THE IFS FEMTOSECOND LASER.

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

  MAUDE report 25319762 ↗
• InjuryMay 28, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT FOLLOWING TREATMENT WITH THE IFS FEMTOSECOND LASER BETWEEN JANUARY AND JUNE 2023, THREE PATIENTS EXPERIENCED STRIAE FLAP DISPLACEMENT IN ONE EYE. THE PATIENTS HAD TO RETURN FOR FLAP LIFT, WASH AND RINSE. NO FURTHER INFORMATION WAS PROVIDED. THROUGH FOLLOW-UP, ADDITIONAL INFORMATION WAS OBTAINED; HOWEVER, IT IS UNCLEAR TO WHICH OF THE THREE PATIENTS THIS INFORMATION PERTAINS. THEREFORE, THIS INFORMATION IS BEING INCLUDED IN ALL CORRESPONDING COMPLAINT FILES. ONE (1) PATIENT HAS LEFT EYE (OS) BEST CORRECTED VISUAL ACUITY (BCVA) PREOP 6/6 AND 6/7 POST FLAP LIFT. THE REST HAVE ACHIEVED UNCORRECTED VISUAL ACUITY (UCVA) POST FLAP LIFT 6/6 OR ABOVE. ONE WITH UCVA 6/7.5 AND BCVA OF 6/6. NO ONE LOST MORE THAN 2 LINES OF BCVA. NOTE: THIS REPORT PERTAINS TO THE PATIENT INTERFACE FOR ONE OF THE THREE PATIENTS. A SEPARATE REPORT IS BEING SUBMITTED FOR THE ASSOCIATED IFS FEMTOSECOND LASER. ADDITIONALLY, SEPARATE REPORTS ARE BEING SUBMITTED FOR THE PATIENT INTERFACE FOR THE REMAINING TWO PATIENTS, AS WELL AS THE IFS FEMTOSECOND LASER.

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

  MAUDE report 25319652 ↗
• InjuryMay 14, 2026Device Difficult to Setup or Prepare; Appropriate Device Problem Term/Code Not Available; Noise, Audible

  IT WAS REPORTED THAT WHEN USING THE PATIENT INTERFACE (PI) THERE WERE ISSUES WITH SUCTION RINGS. THEY WERE VERY STIFF, CREAKY AND DIFFICULT TO USE, WHICH AFFECTED THE MENISCUS AND EPITHELIUM (SLIP) AND CAUSED ABRASIONS IN BILATERAL EYES WHICH REQUIRED THE APPLICATION OF BCL. THE PROCEDURE WAS COMPLETED. NO FURTHER INFORMATION WAS PROVIDED. THIS REPORT IS 2 OF 2 REPORTED.

  Patient problems: Corneal Abrasion

  MAUDE report 25178858 ↗
• InjuryMay 14, 2026Device Difficult to Setup or Prepare; Appropriate Device Problem Term/Code Not Available; Noise, Audible

  IT WAS REPORTED THAT WHEN USING THE PATIENT INTERFACE (PI) THERE WERE ISSUES WITH SUCTION RINGS. THEY WERE VERY STIFF, CREAKY AND DIFFICULT TO USE, WHICH AFFECTED THE MENISCUS AND EPITHELIUM (SLIP) AND CAUSED ABRASIONS IN BILATERAL EYES WHICH REQUIRED THE APPLICATION OF BCL. THE PROCEDURE WAS COMPLETED. NO FURTHER INFORMATION WAS PROVIDED. THIS REPORT IS 1 OF 2 REPORTED.

  Patient problems: Corneal Abrasion

  MAUDE report 25178831 ↗