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 Code	Visual Impairment (2138)
Date of Event	01/29/2025
Type of Reportable Event	Serious Injury
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).
Event or Problem Description
A site reported to rxsight that a light adjustable lens+ (lal+, sn (b)(6), +19.5d) was explanted from the patient's right eye due to patient dissatisfaction with vision.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide additional information to the following sections: b7, d9, h6, h10.The patient's light adjustable lens+ (lal+, sn (b)(6), +19.5d) was explanted due to dissatisfaction with vision after one light treatment and replaced with a toric iol from a different manufacturer.The patient continued to experience vision issues after the iol exchange, including iol misalignment and repositioning procedure, amaurosis fugax, and floaters.Despite the doctor's explanation that another iol exchange will not resolve the patient's issues with floaters or amaurosis fugax, the patient insisted upon exchanging the toric lens for a standard monofocal.The iol exchange was performed on (b)(6) 2025, and a monofocal iol was implanted as a replacement.

• 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: 21575601
• Report Number: 3012712027-2025-00067
• Device Sequence Number: 8751013
• Product Code: PZK
• UDI-Device Identifier: 00818806021576
• UDI-Public: 01008188060215761123122617261130
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 10/22/2025

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: 60007
• Device Catalogue Number: 60007
• Device Lot Number: L08-005664
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/10/2025
• Supplement Date Received by Manufacturer: 09/22/2025
• Initial Report FDA Received Date: 03/11/2025
• Supplement Report FDA Received Date: 10/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/26/2023
• 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: 66 YR
• Patient Sex: Female