IFS ADVANCED FEMTOSEC LASER J20007DRecalls & reported problems

Summary

The FDA's MAUDE database contains 647 adverse event reports that list this exact device (DI 05050474573468), received between Sep 2, 2016 and Aug 14, 2026 — classified as 638 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (12 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 647 reports, in the reporter's own words as published by the FDA.

• InjuryAug 14, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient developed Diffuse Lamellar Keratitis (DLK) following the last surgery day in (b)(6) 2026. The DLK grade was not provided. The patient was treated with oral steroids per the physician's standard DLK treatment protocol. Follow-up information indicated that the DLK resolved with treatment, the patient was doing well, and there was no loss of Best Corrected Visual Acuity (BCVA). No patient identifiers or additional information were provided.

  Patient problems: Keratitis

  MAUDE report 50261183 ↗
• InjuryAug 14, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient developed Diffuse Lamellar Keratitis (DLK) following the last surgery day in (b)(6) 2026. The DLK grade was not provided. The patient was treated with oral steroids per the physician's standard DLK treatment protocol. Follow-up information indicated that the DLK resolved with treatment, the patient was doing well, and there was no loss of Best Corrected Visual Acuity (BCVA). No patient identifiers or additional information were provided.

  Patient problems: Keratitis

  MAUDE report 50261169 ↗
• InjuryMay 27, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IFS ADVANCED FEMTOSECOND LASER SYSTEM WAS ASSOCIATED WITH A PATIENT WHO DEVELOPED POSTOPERATIVE COMPLICATIONS, LIKELY DUE TO EYE RUBBING, REQUIRING AN EPITHELIAL SCRUB FOR A MINOR INFECTION. THE PATIENT REMAINED UNDER TREATMENT WITH STABLE 20/20 VISION AND NO DECREASE IN BEST CORRECTED VISUAL ACUITY (BCVA). THE EVENT WAS REPORTED AS AN EPITHELIAL-RELATED ISSUE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Eye Infections; Eye Injury

  MAUDE report 25302157 ↗
• MalfunctionApr 29, 2026Mechanical Problem

  IT WAS REPORTED BY THE CUSTOMER THAT THERE WAS A MODE LOCK ERROR DURING TREATMENT, WHICH INTERRUPTED THE CONTINUATION OF THE TREATMENT PROCESS. BASED ON THE FOLLOW UP RESPONSE WE CONFIRMED THAT THE LASER WOULD NOT RECOVER IN A REASONABLE TIME AND PROCEDURE WAS COMPLETED WITH PHOTOREFRACTIVE KERATECTOMY (PRK) AND NO NEGATIVE RESULTS. THERE WAS NO PATIENT INJURY. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25038332 ↗
• InjuryMar 11, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT PRESENTED WITH A DISLOCATED FLAP ON THE RIGHT EYE AT ONE DAY POST-OP. DOCTOR HAD TO REFLOAT THE FLAP. NO ADDITIONAL INFORMATION WAS PROVIDED.

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

  MAUDE report 24575247 ↗
• InjuryNov 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CUSTOMER REPORTED SIGNIFICANT VERTICAL GAS BREAKTHROUGH WITH 105M FLAP, DESCRIBED AS SINGLE LARGE AREA DURING SECOND HALF OF FLAP, NO SUCTION LOSS, AND SURGERY WAS ABORTED. DELAY IN PROCEDURE WAS 1 WEEK. PHOTOREFRACTIVE KERATITIS (PRK) PERFORMED ON (B)(6). PATIENT WAS NOT PRESCRIBED MEDICATION (OUTSIDE OF STANDARD OF CARE). BEST CORRECTED VISUAL ACUITY (BSCVA) PRE-OPERATIVE: 20/20. BEST CORRECTED VISUAL ACUITY (BSCVA) POST-OPERATIVE: ONLY HAD POST ONE DAY 1 VISIT AFTER PRK, SO TOO EARLY.

  Patient problems: Eye Injury; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23661693 ↗
• InjuryNov 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CUSTOMER REPORTED SIGNIFICANT VERTICAL GAS BREAKTHROUGH WITH A THINNER FLAP (95 MICRONS) FLAP WITH POCKET TURNED OFF; IT HAPPENED IN MULTIPLE AREAS DURING THE LAST 1/2 OF THE CUT, NO SUCTION LOSS, SURGERY WAS ABORTED. DOCTOR STATES PATIENT IS DOING OK AND IS FULLY RECOVERED. PATIENT WAS NOT PRESCRIBED MEDICATION (OUTSIDE OF STANDARD OF CARE). BEST CORRECTED VISUAL ACUITY (BSCVA) PRE-OPERATIVE: 20/20. BEST CORRECTED VISUAL ACUITY (BSCVA) POST-OPERATIVE: 20/20.

  Patient problems: Eye Injury; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23661450 ↗
• InjuryJun 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE COMPLAINT PERTAINS TO AN INTRAOPERATIVE EVENT OF VERTICAL GAS BREAKTHROUGH REPORTED BY THE CUSTOMER. WHILE THE FIRST EYE WAS SUCCESSFULLY TREATED, THE FLAP ON THE SECOND EYE COULD NOT BE LIFTED DUE TO THE ESCAPE OF GAS BUBBLES. THE CERTIFIED SURGEON, OBSERVED THE GAS BREAKTHROUGH AND SOUGHT CLARIFICATION REGARDING THE APPROPRIATE TIMEFRAME FOR PERFORMING THE PHOTOREFRACTIVE KERATECTOMY (PRK) PROCEDURE ON THE AFFECTED EYE. OUR CLINICAL APPLICATION SPECIALIST (CAS) EXPLAINED THAT THERE IS NO SPECIFIC RECOMMENDATION FOR THE TIMEFRAME, LEAVING THE DECISION TO THE SURGEON'S DISCRETION, AND ADVISED AGAINST LIFTING THE FLAP IN SUCH SITUATIONS. NO INTRAOPERATIVE INTERVENTION NECESSARY. FLAP WAS NOT LIFTED. NO MEDICATION OUTSIDE THE STANDARD OF CARE WAS PRESCRIBED. PATIENT OUTCOME AFTER THE PRK PROCEDURE WAS 20/30-2, WITH PIN HOLE 20/20+1 ON THE FIRST DAY FOLLOWING SURGERY. NOTE: THIS IS REPORT 1 OF 2.

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

  MAUDE report 22283544 ↗
• InjuryMay 14, 2025Mechanical Problem; Communication or Transmission Problem; Mechanical Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT PATIENT HAD THIN FLAP AND MICRO STRIAE. AT ONE DAY POST PATIENT HAD FLAP RELIFTED AND SMOOTHED OUT. PATIENT IS IN GOOD CONDITION WITH NORMAL HEALING. IT WAS ALSO REPORTED THAT SYSTEM WAS GETTING GALVO ERROR 211 AND VIDEO COMMUNICATION ISSUES ERROR 601. NO ADDITIONAL INFORMATION WAS PROVIDED.

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

  MAUDE report 22020381 ↗
• MalfunctionMay 14, 2025Mechanical Problem; Communication or Transmission Problem; Mechanical Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT PATIENT HAD THIN FLAP AND MICRO STRIAE ON LEFT EYE. AT ONE DAY POST PATIENT HAD FLAP RELIFTED AND SMOOTHED OUT. PATIENT HAD INFECTION ON HIS LEFT EYE WHICH IS NOW CURRENTLY BEING TREATED WITH ANTIBIOTICS. IT WAS ALSO REPORTED THAT SYSTEM WAS GETTING GALVO ERROR 211 AND VIDEO COMMUNICATION ISSUES ERROR 601. NO ADDITIONAL INFORMATION WAS PROVIDED.

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

  MAUDE report 22020372 ↗
• InjuryMay 14, 2025Mechanical Problem; Communication or Transmission Problem; Mechanical Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT PATIENT HAD THIN FLAP AND MICRO STRIAE. AT ONE DAY POST PATIENT HAD FLAP RELIFTED AND SMOOTHED OUT. PATIENT IS IN GOOD CONDITION WITH NORMAL HEALING. IT WAS ALSO REPORTED THAT SYSTEM WAS GETTING GALVO ERROR 211 AND VIDEO COMMUNICATION ISSUES ERROR 601. NO ADDITIONAL INFORMATION WAS PROVIDED.

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

  MAUDE report 22020360 ↗
• InjuryMay 14, 2025Mechanical Problem; Communication or Transmission Problem; Mechanical Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT PATIENT HAD THIN FLAP AND MICRO STRIAE. AT ONE DAY POST PATIENT HAD FLAP RELIFTED AND SMOOTHED OUT. PATIENT IS IN GOOD CONDITION WITH NORMAL HEALING. IT WAS ALSO REPORTED THAT SYSTEM WAS GETTING GALVO ERROR 211 AND VIDEO COMMUNICATION ISSUES ERROR 601. NO ADDITIONAL INFORMATION WAS PROVIDED.

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

  MAUDE report 22020348 ↗
• InjuryMay 14, 2025Mechanical Problem; Communication or Transmission Problem; Mechanical Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT PATIENT HAD THIN FLAP AND MICRO STRIAE. AT ONE DAY POST PATIENT HAD FLAP RELIFTED AND SMOOTHED OUT. PATIENT IS IN GOOD CONDITION WITH NORMAL HEALING. IT WAS ALSO REPORTED THAT SYSTEM WAS GETTING GALVO ERROR 211 AND VIDEO COMMUNICATION ISSUES ERROR 601. NO ADDITIONAL INFORMATION WAS PROVIDED.

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

  MAUDE report 22020328 ↗
• InjuryFeb 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CUSTOMER REPORTED THAT A VERTICAL GAS BREAKTHROUGH OCCURRED DURING A LASER TREATMENT ON PATIENT'S OCULUS SINISTER (OS) LEFT EYE OF A FEMALE PATIENT DURING FLAP CREATION. PHYSICIAN SUCCESSFULLY COMPLETED THE SURGICAL TREATMENT ON THE PATIENT'S OCULUS DEXTER (OD) RIGHT EYE BUT HAD TO ABORT THE PROCEDURE ON THE LEFT EYE DUE TO THE BREAKTHROUGH NEAR THE 4 O'CLOCK AREA. THE PATIENT DID NOT SUSTAIN ANY INJURY, BUT THE CASE WAS ABORTED, AND THE PATIENT IS EXPECTED TO RETURN FOR POTENTIAL SURFACE ABLATION IN THE FUTURE. NO FURTHER INFORMATION PROVIDED.

  Patient problems: Eye Injury

  MAUDE report 21339410 ↗
• InjuryNov 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE RASTER PATTERN, IT WAS NOTED THAT THERE WAS A POSSIBLE VERTICAL GAS, BREAKTHROUGH PARA CENTRA TO THE PUPIL. DOCTOR ATTEMPTED TO LIFT THE FLAP. THE FLAP WAS ONLY PARTIALLY DISSECTED AND DOCTOR ELECTED TO ABORT THE PROCEDURE. PATIENT WILL RETURN FOR PHOTOREFRACTIVE KERATECTOMY (PRK) AT A LATER DATE. DOCTOR STATED NO PATIENT INJURY AND NO FURTHER SURGICAL INTERVENTION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Eye Injury; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20685097 ↗
• InjurySep 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD PRESENTED POST OP WITH VERTICAL GAS BREAKTHROUGH (VGB). NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Eye Injury

  MAUDE report 20286702 ↗
• InjuryAug 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD LASIK TREATMENT DONE ON BOTH EYES (OU) ON (B)(6) 2024 AND CALLED DOCTOR'S OFFICE ON (B)(6) 2024 STATING HE FEELS HE HAS BEEN LIGHT SENSITIVE SINCE TREATMENT IN BOTH EYES. HE ONLY GOES INTO HIS WORK OFFICE TWICE A WEEK WHERE MORE LED ARTIFICIAL LIGHTING IS AND SAYS THAT'S WHEN HE REALLY NOTICES IT. POST-OP PATIENTS USE PRED-MOXI FOUR TIMES A DAY (QID) FOR 1 WEEK AND THEN STOP, BUT FOR THE TRANSIENT LIGHT SENSITIVITY SYNDROME (TLSS) CASES, THEY ARE PUT ON A TAPER REGIMEN OF PRED-ACETATE 1%. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Visual Disturbances

  MAUDE report 20029880 ↗
• InjuryAug 9, 2024Computer Software Problem; Adverse Event Without Identified Device or Use Problem; Computer Software Problem; Adverse Event Without Identified Device or Use Problem

  CUSTOMER REPORTED A CASE OF TRANSIENT LIGHT SENSITIVITY SYNDROME ON A PATIENT. CUSTOMER TYPICALLY HAVE THEIR POST-OP PATIENT USE PRED-MOXI QID FOR 1 WEEK, AND THEN STOP. FOR CASES OF TLSS, THE CUSTOMER PRESCRIBE THEM ON A TAPER REGIMEN OF PRED-ACETATE 1%. PRE-SURGERY BEST CORRECTED VISUAL ACUITY (BCVA): 20/15. BCVA AND UNCORRECTED VISUAL ACUITY VA FOLLOW UP SURGERY: BCVA: 20/15, UCVA: 20/15. LASIK PERFORMED BOTH EYES (OU), BUT ONLY RIGHT EYE (OD) AFFECTED. PATIENT STARTED NOTICING SYMPTOMS ON APPROXIMATELY (B)(6), BUT CALLED THE OFFICE ON (B)(6). CUSTOMER SAW PATIENT ON(B)(6). PT IS SCHEDULED FOR A FOLLOW UP APPOINTMENT ON (B)(6) FOR A POST-OP ONCE STEROID REGIMEN IS DONE. PT KNOWS TO CALL BACK BEFORE (B)(6) IF THERE IS NO IMPROVEMENT OR IF THINGS GET WORSE. THE SURGEON VERIFIED THAT THEY ALL RESOLVED WITHIN A COUPLE DAYS OF STARTING THE STEROID DROP REGIMEN PER FOLLOW UP.

  Patient problems: Visual Disturbances

  MAUDE report 19950246 ↗
• InjuryAug 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CUSTOMER REPORTED A CASE OF TRANSIENT LIGHT SENSITIVITY SYNDROME ON A PATIENT. CUSTOMER TYPICALLY HAVE THEIR POST-OP PATIENT USE PRED-MOXI QID FOR 1 WEEK, AND THEN STOP. FOR CASES OF TLSS, THE CUSTOMER PRESCRIBE THEM ON A TAPER REGIMEN OF PRED-ACETATE 1%. ALL PATIENTS ARE DOING GOOD NOW. PRE-SURGERY BEST CORRECTED VISUAL ACUITY (BCVA): 20/15. BCVA AND UNCORRECTED VISUAL ACUITY VA FOLLOW UP SURGERY: BCVA: 20/20 UCVA: 20/25. LASIK PERFORMED RIGHT EYE (OD) ONLY, SO, OD AFFECTED. PATIENT STARTED NOTICING SYMPTOMS ON 7/1, BUT CALLED THE OFFICE ON 7/10. CUSTOMER SAW PATIENT ON 7/11. PT IS SCHEDULED FOR A FOLLOW UP APPOINTMENT ON 7/24 FOR A POST-OP ONCE STEROID REGIMEN IS DONE. PT KNOWS TO CALL BACK BEFORE 7/24 IF THERE IS NO IMPROVEMENT OR IF THINGS GET WORSE. THE SURGEON VERIFIED THAT THEY ALL RESOLVED WITHIN A COUPLE DAYS OF STARTING THE STEROID DROP REGIMEN PER FOLLOW UP.

  Patient problems: Visual Disturbances

  MAUDE report 19940417 ↗
• InjuryJul 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CUSTOMER REPORTED PATIENT'S FIRST EYE IS +1.75-1.50 X 130, AND THERE ARE A FEW WRINKLES INFEROMEDIAL JUST OUTSIDE THE PUPILLARY SPACE. PHYSICIAN ASSUMED THESE WRINKLES CAUSED THE ASTIGMATISM. NO FURTHER INFORMATION ABOUT PATIENT WAS PROVIDED. ADDITIONAL INFORMATION WAS RECEIVED, THE DOCTOR WAS GOING TO HAVE THE PATIENT USE THE STEROID DROPS THEN ASSESS IF HE NEEDED TO LIFT AND RINSE.

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

  MAUDE report 19667211 ↗
• InjuryMar 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CUSTOMER HAD A SMALL VERTICAL GAS BREAKTHROUGH INFERONASAL TO THE PUPIL RIGHT EYE ON THEIR LAST PATIENT OF THE DAY. DOCTOR LIFTED THE FLAP AND COMPLETED THE LASIK PROCEDURE WITHOUT ISSUE. NO FURTHER INFORMATION PROVIDED.

  Patient problems: Eye Injury

  MAUDE report 18994827 ↗
• MalfunctionJan 31, 2024Mechanical Problem; Unintended System Motion; Mechanical Problem; Unintended System Motion

  IT WAS REPORTED THAT THE SPRING BROKE ON THE JOYSTICK AND CAN'T FIND NEUTRAL. IT KEEPS GOING UP OR GOING DOWN AND NOT STOPPING WITH PATIENT INVOLVEMENT. IT WAS REPORTED THAT THERE WAS NO PATIENT INTERVENTION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18619906 ↗
• InjuryDec 29, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CUSTOMER REPORTED A VERTICAL GAS BREAKTHROUGH WHILE CREATING A FLAP IN PATIENT'S EYE FOR A LASIK PROCEDURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A DIFFERENT PATIENT INTERFACE.

  Patient problems: Eye Injury

  MAUDE report 18422074 ↗
• InjuryDec 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A LASER VISION CORRECTION PATIENT HAD SURGERY ON (B)(6), 2023 AND PRESENTED ON (B)(6), 2023 WITH STAGE 3 DIFFUSE LAMELLAR KERATITIS (DLK) IN BOTH EYES. THE TOPICAL STEROID DOSAGE WAS INCREASED. IT WAS STATED THAT THE PATIENT HAD NO LOSS OF BEST CORRECTED VISUAL ACUITY (BCVA). THE PATIENT HAD NO COMPLAINTS. IT WAS REPORTED THAT THE EVENT WAS NOT LASTING AND DISABLING, SIGNIFICANTLY INTERFERING WITH DAILY ACTIVITIES. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Keratitis

  MAUDE report 18323214 ↗
• InjuryJun 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CUSTOMER REPORTED THAT A PATIENT PRESENTED WITH MILD CENTRAL CORNEAL HAZE AFTER LASIK TREATMENT. THE HAZE RESOLVED WITH THE NORMAL POST OPERATIVE STEROID USE. PHYSICIAN HAS HAD MULTIPLE LASIK CASES WITHOUT CORNEAL HAZE. PHYSICIAN PLANS TO REVIEW THE SITE¿S INSTRUMENT PREPARATION/STERILIZATION PROCESS. PER FOLLOW-UP, PHYSICIAN CANNOT REMEMBER THE PATIENTS. THERE WERE ONLY 2, AND I HAVE NOT SEEN ANYONE ELSE SINCE THEN. PATIENT WAS GIVEN PREDNISOLONE ACETATE - THE NORMAL DROP FOR POST OP, BUT PHYSICIAN INCREASED THE FREQUENCY TO 6X/DAY INSTEAD OF 4X/DAY TO HOPEFULLY HELP WITH THE HAZE. THIS REPORT IS FOR PATIENT 2 OF 2.

  Patient problems: Corneal Clouding/Hazing

  MAUDE report 17146385 ↗