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

Model Number	61002
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Type of Reportable Event	Serious Injury
Event or Problem Description
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 prior to approval from the fda; this claim is incorrect.Rxsight has multiple controls in place to prevent the shipment of product prior to approval.Per rxsight records, the implant occurred on (b)(6) 2024, and the redundant uv protection (referred to as "active shield" in the medwatch report) was approved by the fda as part of p160055/s015 on april 20, 2021.Therefore, the lens was approved by the fda prior to implantation.
Additional Manufacturer Narrative
The device history record for the device in question was reviewed and there were no discrepancies or unusual findings.Manufacturer reference #: (b)(4).

• 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: 22812042
• Report Number: 3012712027-2025-00283
• Device Sequence Number: 20747496
• Product Code: PZK
• UDI-Device Identifier: 00818806020029
• UDI-Public: 010081880602002911221031
• 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: Consumer,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/14/2025

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
• Device Catalogue Number: 61002
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/04/2025
• Initial Report FDA Received Date: 08/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/31/2022
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female