WAVELIGHT EX500 EXCIMER LASER 8065990794Recalls & reported problems

Summary

The FDA's MAUDE database contains 109 adverse event reports that list this exact device (DI 00380659907944), received between Mar 4, 2021 and Dec 26, 2025 — classified as 92 injuries, 17 malfunctions.

The most frequently reported specific device problem is “Failure to Capture” (9 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 109 reports, in the reporter's own words as published by the FDA.

• InjuryDec 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT THE PATIENT VISUAL ACUITY WAS STABLE AND CLEAR BUT THE PATIENT HAS EXPERIENCED LONGSTANDING FLOATERS AND FLASHES IN PERIPHERY IN THE RIGHT EYE AFTER REFRACTIVE SURGERY ALONG WITH APPLICATION OF MEDICATION. PATIENT REPORTS HAS NOT BEEN USING LID SCRUBS. THERE ARE TWO RELATED REPORTS FOR THIS PATIENT. THIS REPORT ADDRESSES THE PATIENT'S RIGHT EYE AND ANOTHER MANUFACTURER REPORT WILL BE FILED FOR THE FELLOW EYE.

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

  MAUDE report 23896152 ↗
• InjuryDec 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT THE PATIENT VISUAL ACUITY WAS STABLE AND CLEAR BUT THE PATIENT HAS EXPERIENCED LONGSTANDING FLOATERS AND FLASHES IN PERIPHERY IN THE LEFT EYE AFTER REFRACTIVE SURGERY ALONG WITH APPLICATION OF MEDICATION. PATIENT REPORTS HAS NOT BEEN USING LID SCRUBS. THERE ARE TWO RELATED REPORTS FOR THIS PATIENT. THIS REPORT ADDRESSES THE PATIENT'S LEFT EYE AND ANOTHER MANUFACTURER REPORT WILL BE FILED FOR THE FELLOW EYE.

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

  MAUDE report 23896151 ↗
• MalfunctionDec 16, 2025Contamination; Product Quality Problem; Contamination; Product Quality Problem

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DIAGNOSTIC DEVICE IMAGE USED LOOKED DIFFERENT AND MEIBOMIAN DEBRIS STILL PRESENT IN LEFT EYE DURING REFRACTIVE SURGERY. THERE ARE TWO RELATED REPORTS FOR THIS PATIENT. THIS REPORT ADDRESSES THE PATIENT (B)(6), LEFT EYE AND ANOTHER MANUFACTURER REPORT WILL BE FILED FOR THE FELLOW EYE.

  Patient problems: Insufficient Information

  MAUDE report 23813801 ↗
• MalfunctionDec 12, 2025Contamination; Product Quality Problem; Contamination; Product Quality Problem

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT THE SYSTEM WAS READY TO CAPTURE THE INFRARED IMAGE THE DIAGNOSTIC DEVICE IMAGE APPEARED DIFFERENT THAN EXPECTED. ADDITIONALLY, IT WAS REPORTED THAT MEIBOMIAN DEBRIS WAS PRESENT IN THE RIGHT EYE POSTOPERATIVELY REFRACTIVE SURGERY. THERE ARE TWO RELATED REPORTS FOR THIS PATIENT. THIS REPORT ADDRESSES THE PATIENT (B)(6), RIGHT EYE AND ANOTHER MANUFACTURER REPORT WILL BE FILED FOR THE FELLOW EYE

  Patient problems: Insufficient Information

  MAUDE report 23789077 ↗
• InjuryNov 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT THE PATIENT HAD EXPERIENCED OVER CORRECTION IN THE LEFT EYE WITH THE REFRACTIVE OUTCOME WAS GREATER THAN ONE DIOPTER IN MANIFEST REFRACTION SPHERICAL EQUIVALENT TREATMENT VALUES AFTER REFRACTIVE SURGERY.

  Patient problems: Visual Impairment

  MAUDE report 23641402 ↗
• MalfunctionSep 19, 2025Unexpected Therapeutic Results; Unexpected Therapeutic Results

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE TREATMENT IN THE LEFT EYE OF A PATIENT, THE SYSTEM FLAP HAS STARTED TO COME INTO RANGE WHILE THE TREATMENT WAS FIRING. THE LIGHTS NEEDED TO BE TURNED DOWN TO EXPAND A SMALL PUPIL, THE DOCTOR COULD NOT SEE THE FLAP GOING ONTO THE ABLATION AREA ALERTED AND PULLED THE FLAP BACK ACCORDINGLY BUT SOME OF THE TREATMENT APPEARED TO BE BLOCKED BY THE FLAP PRIOR RESULTING IN AN INCOMPLETE CORNEAL ABLATION DURING LASIK SURGERY. THE PATIENT IS EXPERIENCING GOOD VISUAL OUTCOMES IN THAT LEFT EYE. RIGHT WAS UNAFFECTED AND TREATED WITH NO ISSUES.

  Patient problems: Insufficient Information

  MAUDE report 23095165 ↗
• InjuryMar 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT THE PATIENT HAD EXPERIENCED DIFFUSE LAMELLAR KERATITIS AND CENTRAL TOXIC KERATOPATHY, WITH SPECIFIC SYMPTOMS INCLUDING BLURRY VISION AND LIGHT SENSITIVITY IN THE LEFT EYE AFTER LASIK SURGERY. THE PATIENT IS CURRENTLY UNDERGOING TREATMENT WITH ORAL MEDICATIONS AND DUREZOL, BUT THE SYMPTOMS HAVE NOT RESOLVED. THERE ARE MULTIPLE RELATED REPORTS FOR THIS EVENT. THIS REPORT ADDRESSES THE PATIENT (B)(6), LEFT EYE AND OTHER MANUFACTURER REPORTS WILL BE FILED.

  Patient problems: Blurred Vision; Keratitis; Visual Disturbances

  MAUDE report 21650616 ↗
• InjuryMar 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON-HEALTHCARE PROFESSIONAL REPORTED PATIENT DEVELOPED DIFFUSE LAMELLAR KERATITIS OR CENTRAL TOXIC KERATOPATHY WITH POST OPERATIVE SYMPTOMS OF BLURRED VISION, LIGHT SENSITIVITY AND DISCOMFORT IN THE IN THE RIGHT EYE OF THE PATIENT AFTER LASIK SURGERY. PATIENT SYMPTOMS HAVE NOT BEEN RESOLVED AND CURRENTLY UNDERGOING TREATMENT WITH ORALS AND DUREZOL. THERE ARE MULTIPLE RELATED REPORTS FOR THIS EVENT. THIS REPORT ADDRESSES THE PATIENT AP, RIGHT EYE AND OTHER MANUFACTURER REPORTS WILL BE FILED.

  Patient problems: Blurred Vision; Keratitis; Visual Disturbances

  MAUDE report 21645580 ↗
• InjuryMar 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT THE PATIENT HAD EXPERIENCED DIFFUSE LAMELLAR KERATITIS AND CENTRAL TOXIC KERATOPATHY, WITH SPECIFIC SYMPTOMS INCLUDING BLURRY VISION AND LIGHT SENSITIVITY IN THE RIGHT EYE AFTER LASIK SURGERY. THE PATIENT IS CURRENTLY UNDERGOING TREATMENT WITH ORAL MEDICATIONS AND DUREZOL, BUT THE SYMPTOMS HAVE NOT RESOLVED. THERE ARE MULTIPLE RELATED REPORTS FOR THIS EVENT. THIS REPORT ADDRESSES THE PATIENT (B)(6), LEFT EYE AND OTHER MANUFACTURER REPORTS WILL BE FILED.

  Patient problems: Blurred Vision; Keratitis; Visual Disturbances

  MAUDE report 21645566 ↗
• InjuryMar 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT THE PATIENT HAD EXPERIENCED DIFFUSE LAMELLAR KERATITIS AND CENTRAL TOXIC KERATOPATHY, WITH SPECIFIC SYMPTOMS INCLUDING BLURRY VISION AND LIGHT SENSITIVITY IN THE LEFT EYE AFTER LASIK SURGERY. THE PATIENT IS CURRENTLY UNDERGOING TREATMENT WITH ORAL MEDICATIONS AND DUREZOL, BUT THE SYMPTOMS HAVE NOT RESOLVED. THERE ARE MULTIPLE RELATED REPORTS FOR THIS EVENT. THIS REPORT ADDRESSES THE PATIENT SR, LEFT EYE AND OTHER MANUFACTURER REPORTS WILL BE FILED.

  Patient problems: Blurred Vision; Keratitis; Visual Disturbances

  MAUDE report 21645330 ↗
• InjuryMar 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT THE PATIENT HAD EXPERIENCED DIFFUSE LAMELLAR KERATITIS AND CENTRAL TOXIC KERATOPATHY, WITH SPECIFIC SYMPTOMS INCLUDING BLURRY VISION AND LIGHT SENSITIVITY IN THE LEFT EYE AFTER LASIK SURGERY. THE PATIENT IS CURRENTLY UNDERGOING TREATMENT WITH ORAL MEDICATIONS AND DUREZOL, BUT THE SYMPTOMS HAVE NOT RESOLVED. THERE ARE MULTIPLE RELATED REPORTS FOR THIS EVENT. THIS REPORT ADDRESSES THE PATIENT MB, LEFT EYE AND OTHER MANUFACTURER REPORTS WILL BE FILED.

  Patient problems: Blurred Vision; Keratitis; Visual Disturbances

  MAUDE report 21645328 ↗
• InjuryMar 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT THE PATIENT HAD EXPERIENCED DIFFUSE LAMELLAR KERATITIS AND CENTRAL TOXIC KERATOPATHY, WITH SPECIFIC SYMPTOMS INCLUDING BLURRY VISION AND LIGHT SENSITIVITY IN THE LEFT EYE AFTER LASIK SURGERY. THE PATIENT IS CURRENTLY UNDERGOING TREATMENT WITH ORAL MEDICATIONS AND DUREZOL, BUT THE SYMPTOMS HAVE NOT RESOLVED. THERE ARE MULTIPLE RELATED REPORTS FOR THIS EVENT. THIS REPORT ADDRESSES THE PATIENT JH, LEFT EYE AND OTHER MANUFACTURER REPORTS WILL BE FILED.

  Patient problems: Blurred Vision; Keratitis; Visual Disturbances

  MAUDE report 21645195 ↗
• InjuryMar 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT THE PATIENT HAD EXPERIENCED DIFFUSE LAMELLAR KERATITIS AND CENTRAL TOXIC KERATOPATHY, WITH SPECIFIC SYMPTOMS INCLUDING BLURRY VISION AND LIGHT SENSITIVITY IN THE LEFT EYE AFTER LASIK SURGERY. THE PATIENT IS CURRENTLY UNDERGOING TREATMENT WITH ORAL MEDICATIONS AND DUREZOL, BUT THE SYMPTOMS HAVE NOT RESOLVED. THERE ARE MULTIPLE RELATED REPORTS FOR THIS EVENT. THIS REPORT ADDRESSES THE PATIENT BL, LEFT EYE AND OTHER MANUFACTURER REPORTS WILL BE FILED.

  Patient problems: Blurred Vision; Keratitis; Visual Disturbances

  MAUDE report 21645194 ↗
• InjuryMar 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT THE PATIENT HAD EXPERIENCED DIFFUSE LAMELLAR KERATITIS AND CENTRAL TOXIC KERATOPATHY, WITH SPECIFIC SYMPTOMS INCLUDING BLURRY VISION AND LIGHT SENSITIVITY IN THE LEFT EYE AFTER LASIK SURGERY. THE PATIENT IS CURRENTLY UNDERGOING TREATMENT WITH ORAL MEDICATIONS AND DUREZOL, BUT THE SYMPTOMS HAVE NOT RESOLVED. THERE ARE MULTIPLE RELATED REPORTS FOR THIS EVENT. THIS REPORT ADDRESSES THE PATIENT MR, LEFT EYE AND OTHER MANUFACTURER REPORTS WILL BE FILED.

  Patient problems: Blurred Vision; Keratitis; Visual Disturbances

  MAUDE report 21645042 ↗
• InjuryMar 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT THE PATIENT HAD EXPERIENCED DIFFUSE LAMELLAR KERATITIS AND CENTRAL TOXIC KERATOPATHY, WITH SPECIFIC SYMPTOMS INCLUDING BLURRY VISION AND LIGHT SENSITIVITY IN THE RIGHT EYE AFTER LASIK SURGERY. THE PATIENT IS CURRENTLY UNDERGOING TREATMENT WITH ORAL MEDICATIONS AND DUREZOL, BUT THE SYMPTOMS HAVE NOT RESOLVED. THERE ARE MULTIPLE RELATED REPORTS FOR THIS EVENT. THIS REPORT ADDRESSES THE PATIENT (UNK), RIGHT EYE AND OTHER MANUFACTURER REPORTS WILL BE FILED.

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

  MAUDE report 21644904 ↗
• InjuryMar 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT THE PATIENT HAD EXPERIENCED DIFFUSE LAMELLAR KERATITIS AND CENTRAL TOXIC KERATOPATHY, WITH SPECIFIC SYMPTOMS INCLUDING BLURRY VISION AND LIGHT SENSITIVITY IN THE LEFT EYE AFTER LASIK SURGERY. THE PATIENT IS CURRENTLY UNDERGOING TREATMENT WITH ORAL MEDICATIONS AND DUREZOL, BUT THE SYMPTOMS HAVE NOT RESOLVED. THERE ARE MULTIPLE RELATED REPORTS FOR THIS EVENT. THIS REPORT ADDRESSES THE PATIENT (B)(6), LEFT EYE AND OTHER MANUFACTURER REPORTS WILL BE FILED.

  Patient problems: Blurred Vision; Keratitis; Visual Disturbances

  MAUDE report 21644102 ↗
• InjuryMar 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT THE PATIENT EXPERIENCED DIFFUSE LAMELLAR KERATITIS AND CENTRAL TOXIC KERATOPATHY, WITH SPECIFIC SYMPTOMS INCLUDING BLURRY VISION AND LIGHT SENSITIVITY IN THE RIGHT EYE AFTER LASIK SURGERY. THE PATIENT IS CURRENTLY UNDERGOING TREATMENT WITH ORAL MEDICATIONS AND DUREZOL, BUT THE SYMPTOMS HAVE NOT RESOLVED. THERE ARE MULTIPLE RELATED REPORTS FOR THIS EVENT. THIS REPORT ADDRESSES THE PATIENT (B)(6), RIGHT EYE AND OTHER MANUFACTURER REPORTS WILL BE FILED.

  Patient problems: Blurred Vision; Keratitis; Visual Disturbances

  MAUDE report 21643922 ↗
• InjuryMar 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT THE PATIENT HAD EXPERIENCED DIFFUSE LAMELLAR KERATITIS AND CENTRAL TOXIC KERATOPATHY, WITH SPECIFIC SYMPTOMS INCLUDING BLURRY VISION AND LIGHT SENSITIVITY IN THE RIGHT EYE AFTER LASIK SURGERY. THE PATIENT IS CURRENTLY UNDERGOING TREATMENT WITH ORAL MEDICATIONS AND DUREZOL, BUT THE SYMPTOMS HAVE NOT RESOLVED. THERE ARE MULTIPLE RELATED REPORTS FOR THIS EVENT. THIS REPORT ADDRESSES THE PATIENT SR, RIGHT EYE AND OTHER MANUFACTURER REPORTS WILL BE FILED.

  Patient problems: Blurred Vision; Keratitis; Visual Disturbances

  MAUDE report 21643791 ↗
• InjuryMar 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT THE PATIENT HAD EXPERIENCED DIFFUSE LAMELLAR KERATITIS AND CENTRAL TOXIC KERATOPATHY, WITH SPECIFIC SYMPTOMS INCLUDING BLURRY VISION AND LIGHT SENSITIVITY IN THE RIGHT EYE AFTER LASIK SURGERY. THE PATIENT IS CURRENTLY UNDERGOING TREATMENT WITH ORAL MEDICATIONS AND DUREZOL, BUT THE SYMPTOMS HAVE NOT RESOLVED. THERE ARE MULTIPLE RELATED REPORTS FOR THIS EVENT. THIS REPORT ADDRESSES THE PATIENT BL, RIGHT EYE AND OTHER MANUFACTURER REPORTS WILL BE FILED.

  Patient problems: Blurred Vision; Keratitis; Visual Disturbances

  MAUDE report 21643659 ↗
• InjuryMar 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT THE PATIENT EXPERIENCED DIFFUSE LAMELLAR KERATITIS AND CENTRAL TOXIC KERATOPATHY, WITH SPECIFIC SYMPTOMS INCLUDING BLURRY VISION AND LIGHT SENSITIVITY IN THE RIGHT EYE AFTER LASIK SURGERY. THE PATIENT IS CURRENTLY UNDERGOING TREATMENT WITH ORAL MEDICATIONS AND DUREZOL, BUT THE SYMPTOMS HAVE NOT RESOLVED. THERE ARE MULTIPLE RELATED REPORTS FOR THIS EVENT. THIS REPORT ADDRESSES THE PATIENT (B)(6), RIGHT EYE AND OTHER MANUFACTURER REPORTS WILL BE FILED.

  Patient problems: Blurred Vision; Keratitis; Visual Disturbances

  MAUDE report 21643522 ↗
• InjuryMar 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT THE PATIENT HAD EXPERIENCED DIFFUSE LAMELLAR KERATITIS AND CENTRAL TOXIC KERATOPATHY, WITH SPECIFIC SYMPTOMS INCLUDING BLURRY VISION AND LIGHT SENSITIVITY IN THE RIGHT EYE AFTER LASIK SURGERY. THE PATIENT IS CURRENTLY UNDERGOING TREATMENT WITH ORAL MEDICATIONS AND DUREZOL, BUT THE SYMPTOMS HAVE NOT RESOLVED. THERE ARE MULTIPLE RELATED REPORTS FOR THIS EVENT. THIS REPORT ADDRESSES THE PATIENT MR, RIGHT EYE AND OTHER MANUFACTURER REPORTS WILL BE FILED.

  Patient problems: Blurred Vision; Keratitis; Visual Disturbances

  MAUDE report 21643511 ↗
• InjuryMar 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT THE PATIENT EXPERIENCED DIFFUSE LAMELLAR KERATITIS AND CENTRAL TOXIC KERATOPATHY, WITH SPECIFIC SYMPTOMS INCLUDING BLURRY VISION AND LIGHT SENSITIVITY IN THE RIGHT EYE AFTER LASIK SURGERY. THE PATIENT IS CURRENTLY UNDERGOING TREATMENT WITH ORAL MEDICATIONS AND DUREZOL, BUT THE SYMPTOMS HAVE NOT RESOLVED. THERE ARE MULTIPLE RELATED REPORTS FOR THIS EVENT. THIS REPORT ADDRESSES THE PATIENT BK, RIGHT EYE AND OTHER MANUFACTURER REPORTS WILL BE FILED.

  Patient problems: Blurred Vision; Keratitis; Visual Disturbances

  MAUDE report 21643298 ↗
• InjuryMar 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT THE PATIENT EXPERIENCED DIFFUSE LAMELLAR KERATITIS AND CENTRAL TOXIC KERATOPATHY, WITH SPECIFIC SYMPTOMS INCLUDING BLURRY VISION AND LIGHT SENSITIVITY IN THE RIGHT EYE AFTER LASIK SURGERY. THE PATIENT IS CURRENTLY UNDERGOING TREATMENT WITH ORAL MEDICATIONS AND DUREZOL, BUT THE SYMPTOMS HAVE NOT RESOLVED. THERE ARE MULTIPLE RELATED REPORTS FOR THIS EVENT. THIS REPORT ADDRESSES THE PATIENT SL, RIGHT EYE AND OTHER MANUFACTURER REPORTS WILL BE FILED.

  Patient problems: Blurred Vision; Keratitis; Visual Disturbances

  MAUDE report 21643296 ↗
• InjuryMar 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT THE PATIENT HAD EXPERIENCED DIFFUSE LAMELLAR KERATITIS AND CENTRAL TOXIC KERATOPATHY, WITH SPECIFIC SYMPTOMS INCLUDING BLURRY VISION AND LIGHT SENSITIVITY IN THE RIGHT EYE AFTER LASIK SURGERY. THE PATIENT IS CURRENTLY UNDERGOING TREATMENT WITH ORAL MEDICATIONS AND DUREZOL, BUT THE SYMPTOMS HAVE NOT RESOLVED. THERE ARE MULTIPLE RELATED REPORTS FOR THIS EVENT. THIS REPORT ADDRESSES THE PATIENT (B)(6), RIGHT EYE AND OTHER MANUFACTURER REPORTS WILL BE FILED.

  Patient problems: Blurred Vision; Keratitis; Visual Disturbances

  MAUDE report 21642857 ↗
• InjuryMar 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT THE PATIENT HAD EXPERIENCED DIFFUSE LAMELLAR KERATITIS AND CENTRAL TOXIC KERATOPATHY, WITH SPECIFIC SYMPTOMS INCLUDING BLURRY VISION AND LIGHT SENSITIVITY IN THE LEFT EYE AFTER LASIK SURGERY. THE PATIENT IS CURRENTLY UNDERGOING TREATMENT WITH ORAL MEDICATIONS AND DUREZOL, BUT THE SYMPTOMS HAVE NOT RESOLVED. THERE ARE MULTIPLE RELATED REPORTS FOR THIS EVENT. THIS REPORT ADDRESSES THE PATIENT (B)(6)'S, IN THE LEFT EYE AND OTHER MANUFACTURER REPORTS WILL BE FILED.

  Patient problems: Blurred Vision; Keratitis; Visual Disturbances

  MAUDE report 21642641 ↗