MAUDE Adverse Event Report: RXSIGHT, INC. LIGHT ADJUSTABLE LENS+ (LAL+)

Model Number	60007
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Blurred Vision (2137); Visual Disturbances (2140)
Type of Reportable Event	Serious Injury
Event or Problem Description
Rxsight received a medwatch report mw5183895 dated 03/12/2026.In this medwatch report, a patient stated that she had the light adjustable lens+ (lal+) implanted in her right eye with no issues post-implantation; however, after the 1st light adjustment her vision became worse.Per information provided by the treating physician, the patient's right eye was being targeted for plano sphere.Prior to the 1st light treatment on (b)(6) 2025, the patient's uncorrected distance visual acuity (ucdva) was 20/20, manifest refraction (mr) was -0.25 +0.25 x100 with best corrected distance visual acuity (bcdva) being 20/20.After the light treatment on (b)(6) 2025, the patient's ucdva was 20/25+2, mr was plano +0.75 x045 with bcdva 20/20.Patient also reported being light sensitive, having starbursts, shadowing, and ghosting.Furthermore, patient reported that the treating physician noted observing central circle/ring in the iol.The lal+ was later explanted, and the patient had a vitrectomy due to prior yag capsulotomy.The patient alleges, based on information obtained on social media, that the visual disturbances that she experienced were due to non-focused light adjustments; however, there is no clinical evidence suggesting this is a contributing factor.The patient's light treatment data shows there was sufficient dilation for visualization of the optic, the light treatment was in focus and centered, within normal limits, and shows no evidence of prolonged decentration.
Additional Manufacturer Narrative
The device history record for the manufacturing lot was reviewed and there were no discrepancies or unusual findings.Manufacturer reference #: (b)(4).

• Brand Name: LIGHT ADJUSTABLE LENS+ (LAL+)
• Common Device Name: LIGHT ADJUSTABLE LENS+ (LAL+)
• 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: 24782106
• Report Number: 3012712027-2026-00153
• Device Sequence Number: 9925823
• Product Code: PZK
• UDI-Device Identifier: 00818806021590
• UDI-Public: 01008188060215901124061817270531
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P160055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 04/03/2026

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: 60007
• Device Catalogue Number: 60007
• Device Lot Number: L08-006793
• 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: 03/12/2026
• Initial Report FDA Received Date: 04/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/18/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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: Required Intervention
• Patient Age: 67 YR
• Patient Sex: Female