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)
Date of Event	08/26/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
A site reported to rxsight that a patient was implanted with the light adjustable lens+ (lal+, sn (b)(6), +20.0d) on (b)(6) 2024.Postoperatively, the patient underwent 2 light adjustments and no lock-in treatments.In addition, during the postoperative period, the patient was referred to a retina specialist and underwent anti-vascular endothelial growth factor (vegf) injections.On (b)(6) 2025, approximately 11 months after implantation, the lal+ was explanted due to blurred vision.
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).
Additional Manufacturer Narrative
This supplemental report is submitted to provide the results of the investigation and additional information.Updates to sections b5, b7 and h6.
Event or Problem Description
A site reported to rxsight that a bilateral patient was implanted with the light adjustable lens+ (lal+, sn (b)(6), +20.0d) in the right eye on (b)(6) 2024.Postoperatively, the patient's light treatment was delayed due to macular heme and undergoing anti-vascular endothelial growth factor (vegf) injections.The patient underwent 2 light adjustments and no lock-in treatments.The patient complained of blurry vision with ghost image.On (b)(6) 2025, approximately 11 months after implantation, the lal+ was explanted due to blurred vision and visual disturbance.After explantation and lens exchange with a monofocal iol, the patient's symptoms persisted with ghosting image at 4 to 5 feet.The treating physician indicated that ghosting is due to the patient's corneal astigmatism.

• 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: 23873597
• Report Number: 3012712027-2025-00445
• Device Sequence Number: 4619204
• Product Code: PZK
• UDI-Device Identifier: 00818806021583
• UDI-Public: 01008188060215831124041917270331
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P160055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/18/2026

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: L08-006367
• 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: 11/25/2025
• Supplement Date Received by Manufacturer: 02/19/2026
• Initial Report FDA Received Date: 12/22/2025
• Supplement Report FDA Received Date: 03/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/19/2024
• 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: 72 YR
• Patient Sex: Female