VisuMaxRecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 04049471095036), received between Aug 27, 2021 and Apr 7, 2026 — classified as 9 injuries, 1 malfunction.

The most frequently reported specific device problem is “Use of Device Problem” (3 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryApr 7, 2026Use of Device Problem

  IT WAS REPORTED THAT DURING TREATMENT, FLAP WAS CREATED BUT IT APPEARED THAT THERE WAS NO HINGE WHEN LIFTED. CAP COMPLETELY CAME OFF.

  Patient problems: Visual Impairment

  MAUDE report 24811483 ↗
• InjuryJun 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE MANUFACTURER RECEIVED AN ANONYMOUS NOTIFICATION THROUGH BRAZILIAN AUTHORITY ANVISA, IN WHICH THE CLIENT REPORTED THAT THE DEVICE DISPLAYED A ERROR MESSAGE WHEN A FLAP TREATMENT SHOULD BE STARTED AND THE SYSTEM WAS SHUT OFF. THE CLIENT HAD TO RESTART THE EQUIPMENT TO ATTEMPT THE PROCEDURE AGAIN. AFTER REBOOTING, NO ERROR MESSAGE APPEARED, AND THEY WERE ABLE TO PERFORM THE PROCEDURE ON THE FIRST EYE (OD) SUCCESSFULLY. FOR THE SECOND EYE, THERE WAS NO ERROR MESSAGE EITHER, BUT THE FLAP TURNED OUT TOO THIN AND ENDED UP TEARING. AS A RESULT, CLIENT DECIDED TO ABORT THE PROCEDURE ON THE SECOND EYE.

  Patient problems: Visual Impairment

  MAUDE report 22312084 ↗
• InjuryMay 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A HEALTH CARE PROFESSIONAL (HCP) REPORTED THAT A PATIENT MAY HAVE RETAINED LENTICULE FRAGMENT, AND HIS VISION IS DECREASING.

  Patient problems: Visual Impairment

  MAUDE report 21998874 ↗
• InjuryApr 30, 2025Use of Device Problem; Use of Device Problem

  A DIFFICULT CASE WAS REPORTED WITH A SUBSTANDARD OUTCOME FOR ONE PATIENT OD. ORIGINAL TREATMENT WAS A SMILE ATTEMPT WITH SUCTION LOSS IN THE POSTERIOR CUT. SURGEON PROCEEDED WITH A FLAP REPAIR CUT, LIFTED THE FLAP AND TREATED WITH AN EXCIMER LASER. THE PATIENT'S VISION WAS REPORTED TO BE 20/150, HOWEVER, IT WAS NOT SHARED IF THIS WAS UNCORRECTED VISION OR BEST CORRECTED VISION. THUS, IT IS UNCLEAR WHETHER THERE WAS A NEGATIVE IMPACT ON THIS PATIENT. IT CANNOT BE DETERMINED WHETHER THE PATIENT HAS LOST MORE THAN 2 LINES OF THE BEST CORRECTED VISUAL ACUITY (BCVA).

  Patient problems: Insufficient Information

  MAUDE report 21936889 ↗
• MalfunctionJul 16, 2024Unintended Movement; Device Fell; Unintended Movement; Device Fell

  DURING SURGERY, WHILE THE PATIENT WAS LYING ON THE PSS, THE Z-MOTOR BROKE CAUSING THE PSS TO FALL DOWN. WHEN THE INCIDENT HAPPENED THE SURGERY PROCESS HAD NOT START YET. THERE IS NO REPORT OF ANY NEGATIVE IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19757494 ↗
• InjuryOct 24, 2023Use of Device Problem; Use of Device Problem

  IT WAS REPORTED BY THE SURGEON THAT THERE WAS A COMPLICATION WITH A LENTICULE REMOVAL, AND STICKY DISSECTION. LENTICULAR INTERFACE WAS EXTREMELY STICKY ; ONE QUARTER OF SIDE CUT APPEARED TO BE MISSING. THE DOCTOR MENTIONED AN INJURY: IRREGULAR ASTIGMATISM ON PATIENT CORNEA.

  Patient problems: Visual Impairment

  MAUDE report 17997105 ↗
• InjurySep 1, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2023, WE RECEIVED A REPORT THAT A FOLLOW UP OD SURGERY WAS PERFORMED ON A PATIENT. THE PATIENT HAD UNDERWENT A PTK SURGERY AFTER HAVING SMILE SURGERY ON (B)(6) 2023. THE PTK PROCEDURE IS AN AFTER-TREATMENT AND AN ADDITIONAL MEDICAL INTERVENTION WHICH WAS TAKEN IN ORDER TO PREVENT PERMANENT AND/OR TEMPORARY IMPAIRMENT. AT PRESENT, THE PATIENT IS STILL IN THE RECOVERY PERIOD AFTER SURGERY, AND NO MORE TREATMENTS HAVE BEEN PERFORMED.

  Patient problems: Visual Impairment

  MAUDE report 17673869 ↗
• InjuryOct 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A HEALTH CARE PROFESSIONAL (HCP) REPORTED THAT THE PATIENT HAD AN UNEVENTFUL SMILE PROCEDURE OF THE LEFT EYE ON (B)(6), 2022. RIGHT EYE WAS SLIGHTLY OVERCORRECTED AND AN ENHANCEMENT WAS PERFORMED ON (B)(6), 2022, WITH FLAP AND MEL80. FLAP CREATION WAS PERFECT AND IT LIFTED FINE. HYPEROPIC MEL80 ABLATION WAS PERFORMED IMMEDIATELY AFTER THE LIFT. ONCE COMPLETED, A THIN CORNEAL "WAFER" OR "LAYER" WAS NOTICED IN THE STROMAL BED WHEN THE FLAP WAS REPOSITIONED. TWO DAYS LATER, AFTER CONSULTING WITH ANOTHER SURGEON, THE FLAP WAS REPOSITIONED AGAIN WITH CAREFUL ATTENTION TO THE WAFER.

  Patient problems: Eye Injury

  MAUDE report 15642280 ↗
• InjuryOct 13, 2022Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  THE SURGEON REPORTED THAT THE PATIENT DEVELOPED A BUTTONHOLE PARACENTRAL TO THE VISUAL AXIS WHICH HAS RESULTED IN A SMALL STROMAL SCAR. EVALUATION OF THE TREATMENT VIDEO SHOWED THAT THE REPORTED SCAR WAS A RESULT OF REPEATED SUCTION LOSS AND THE IMMEDIATE RESTART OF THE PROCEDURE WITH A DIRTY SURFACE OF THE USED TREATMENT PACK. THE CONSEQUENCE OF THE DIRTY SURFACE WAS AN INCOMPLETE CUT FOLLOWED BY MANIPULATIONS DURING LENTICULE EXTRACTIONS THAT EVENTUALLY CAUSED THE STROMAL SCAR. AN ASSESSMENT OF VISUAL ACUITY OF THE PATIENT CAN ONLY BE MADE CAUTIOUSLY BASED ON THE AVAILABLE DATA. CURRENTLY, THERE IS A LOSS OF VISUAL ACUITY AND THE PATIENT NOTES AN OPACITY THAT HAS CONTINUED TO BE MONITORED.

  Patient problems: Corneal Scar; Eye Injury; Visual Impairment

  MAUDE report 15597276 ↗
• InjuryAug 27, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A HEALTH CARE PROFESSIONAL (HCP) REPORTED THAT A PATIENT WHO WENT THROUGH A SMILE PROCEDURE LOST 3 LINES OF THE BEST CORRECTED VISUAL ACUITY (BCVA). THE PATIENT'S ONE EYE IS 20/20 BUT THE OTHER EYE'S BCVA IS 20/50.

  Patient problems: Visual Impairment

  MAUDE report 12380094 ↗