RxSight Light Delivery Device (LDD) 61002Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00818806020029), received between Jun 12, 2025 and May 29, 2026 — classified as 7 injuries.

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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryMay 29, 2026Adverse Event Without Identified Device or Use Problem

  A SITE REPORTED TO RXSIGHT THAT A PATIENT PRESENTED WITH SIGNS AND SYMPTOMS OF HERPES SIMPLEX VIRUS (HSV) REACTIVATION IN BOTH EYES ONE DAY AFTER BILATERAL SAME-DAY LOCK-IN 2 TREATMENT. THE PATIENT WAS STARTED ON ANTIVIRAL THERAPY. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Keratitis

  MAUDE report 25338390 ↗
• InjuryMar 2, 2026Adverse Event Without Identified Device or Use Problem

  A PHYSICIAN REPORTED TO RXSIGHT THAT A PATIENT WAS DIAGNOSED WITH HERPES ZOSTER OPHTHALMICUS (HZO) WITH CORNEAL INVOLVEMENT ON (B)(6) 2026 FOLLOWING A RECENT LOCK-IN TREATMENT ON (B)(6) 2026. ANTIVIRAL MEDICATION WAS PRESCRIBED FOR THE PATIENT. ON (B)(6) 2026, PATIENT'S SYMPTOMS WERE RESOLVED. THE TREATING PHYSICIAN KEPT PATIENT ON ANTIVIRAL MEDICATION AS PROPHYLACTIC TREATMENT THROUGH THE FINAL LOCK IN.

  Patient problems: Keratitis

  MAUDE report 24491855 ↗
• InjuryOct 31, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A SITE REPORTED TO RXSIGHT THAT A PATIENT PRESENTED WITH SIGNS AND SYMPTOMS OF HERPES SIMPLEX VIRUS (HSV) REACTIVATION IN BOTH EYES ON (B)(6) 2025, FOLLOWING THE FIRST LIGHT TREATMENT THAT WAS PERFORMED ON (B)(6) 2025. THE PATIENT WAS PRESCRIBED ANTIVIRAL AND ANTIBIOTIC MEDICATION TO TREAT THE INFECTION, WHICH RESOLVED THEREAFTER.

  Patient problems: Keratitis

  MAUDE report 23439270 ↗
• InjuryOct 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A SITE REPORTED TO RXSIGHT THAT A PATIENT WITH A HISTORY OF HERPES SIMPLEX VIRUS (HSV) DEVELOPED HSV KERATITIS APPROXIMATELY 1 WEEK FOLLOWING THE PATIENT'S FIRST LIGHT ADJUSTMENT TREATMENT. THE PATIENT WAS SUBSEQUENTLY PRESCRIBED ANTIVIRAL MEDICATION TO TREAT THE HSV KERATITIS. HSV KERATITIS WAS RESOLVED AND THE PATIENT COMPLETED ALL REMAINING LIGHT ADJUSTMENTS AND LOCK-IN TREATMENTS.

  Patient problems: Keratitis

  MAUDE report 23330379 ↗
• InjuryAug 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RXSIGHT RECEIVED A MEDWATCH REPORT MW5173530 DATED 08/04/2025. A PATIENT STATED THAT SHE HAD THE LIGHT ADJUSTABLE LENSES (LALS) IMPLANTED AND HER IRIS CHANGED COLOR FROM GREEN TO BLUE AFTER LIGHT TREATMENTS. THE PATIENT ALSO STATED THAT SHE HAS "EXTREME PAIN EVEN WHEN I WEAR SUNGLASSES". THE PATIENT'S TREATING PHYSICIAN INDICATED TO RXSIGHT THAT THE SURGERY AND LIGHT TREATMENTS WERE UNREMARKABLE. THE PATIENT'S VISUAL ACUITY WAS EXCELLENT, 20/20 OR 20/25 UNCORRECTED DISTANCE VISUAL ACUITY (UCDVA) AND J1 OR J2 UNCORRECTED NEAR VISUAL ACUITY (UCNVA). SOMETIME AFTER THE 2ND LOCK-IN TREATMENT, THE PATIENT STATED THAT HER EYE COLOR CHANGED FROM GREEN TO BLUE. THE TREATING PHYSICIAN CONFIRMED THAT THE EYE COLOR IS BLUE AND CONCENTRICALLY UNIFORM 360 DEGREES. THE TREATING PHYSICIAN RULES OUT IRIS DYSTROPHY OR PIGMENT DISPERSION SYNDROME. LASTLY, THE SURGEON DOES NOT BELIEVE THE LIGHT TREATMENTS ARE RELATED THE PATIENT'S COMPLAINT. RXSIGHT HAD DETERMINED THAT THE PATIENT'S COMPLAINT WAS NOT REPORTABLE; HOWEVER, OUT OF AN ABUNDANCE OF CAUTION, RXSIGHT IS SUBMITTING THIS MDR FOR REVIEW. FURTHERMORE, IN THE MEDWATCH REPORT MW5173530, THE PATIENT/REPORTER CLAIMS THAT THE LENS WAS IMPLANTED PRIO

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

  MAUDE report 22812042 ↗
• InjuryJun 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A SITE REPORTED TO RXSIGHT THAT ON (B)(6) 2024, 1 WEEK FOLLOWING A LIGHT ADJUSTMENT TREATMENT, THE PATIENT WAS PRESCRIBED ANTIVIRAL MEDICATION TO TREAT HERPES ZOSTER KERATITIS WITH MILD UVEITIS. SYMPTOMS WERE RESOLVED AS OF (B)(6) 2024, AND THE PATIENT PROCEEDED TO COMPLETE THE REMAINING LOCK-IN TREATMENTS.

  Patient problems: Keratitis; Uveitis

  MAUDE report 22204132 ↗
• InjuryJun 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A SITE REPORTED TO RXSIGHT THAT ON (B)(6) 2024, 1 WEEK FOLLOWING THE LOCK-IN LIGHT TREATMENT, THE PATIENT WAS PRESCRIBED ANTIVIRAL MEDICATION TO TREAT HERPES ZOSTER OPHTHALMICUS (HZO). TOPICAL STEROID WAS SUBSEQUENTLY ADDED TO TREAT AN ASSOCIATED UVEITIS. SYMPTOMS WERE RESOLVED ON (B)(6) 2025, AND THE PATIENT PROCEEDED TO COMPLETE THE FINAL LOCK-IN LIGHT TREATMENT.

  Patient problems: Uveitis

  MAUDE report 22194530 ↗