MAUDE Adverse Event Report: RXSIGHT, INC. LIGHT DELIVERY DEVICE (LDD)

Model Number	61002-007
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Keratitis (1944)
Date of Event	02/04/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturing records were reviewed and found no deviations, non-conformance's, or other manufacturing issues related to the reported event.Per the instructions for use (ifu), contraindications, "use of the lal is contraindicated in cases where the patient has a history of ocular herpes simplex virus due to the potential for reactivation from exposure to uv light." manufacturer reference #: (b)(4).
Event or Problem Description
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.

• Brand Name: LIGHT DELIVERY DEVICE (LDD)
• Common Device Name: LIGHT DELIVERY DEVICE (LDD)
• Manufacturer (Section D): RXSIGHT, INC.; 100 columbia; aliso viejo CA 92656
• Manufacturer (Section G): RXSIGHT, INC.; 100 columbia; aliso viejo CA 92656
• Manufacturer Contact: jim zhang ; 100 columbia; aliso viejo, CA 92656 ; 9492736163
• MDR Report Key: 25338390
• Report Number: 3012712027-2026-00223
• Device Sequence Number: 14772431
• Product Code: PZK
• UDI-Device Identifier: 00818806020029
• UDI-Public: 00818806020029
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P160055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/29/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 61002-007
• Device Catalogue Number: 61002-007
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/29/2026
• Initial Report FDA Received Date: 05/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/30/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: LIGHT ADJUSTABLE LENS+, PRODUCT #60007.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 60 YR
• Patient Sex: Female