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	Blurred Vision (2137)
Date of Event	11/18/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
A site reported to rxsight that a patient's light adjustable lens+ (lal+, sn (b)(6), +18.5d) was explanted due to the patient's dissatisfaction with the chosen refractive target and a new lal+ (sn (b)(6), +18.5d) implanted as a replacement.
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 device evaluation.Updates to sections h3 and h6.The explanted lal+ was returned to rxsight.A visual inspection found the lens cut into 3 pieces and the haptics missing, all attributed to the lens explantation procedure.Other than this damage, no anomalies were noted on the lal+.Analysis of information provided by the surgeon noted that this lens (os) had been targeted to near vision while the opposing lens (od - not explanted) had been targeted for plano; however, the patient was unable to neuroadapt to the resulting monovision.Based on the available information, the patient's inability to adapt to monovision is the likely cause of the reported patient dissatisfaction with chosen refractive target and lens explant.

• 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 ; 9492736163-159
• MDR Report Key: 23829709
• Report Number: 3012712027-2025-00433
• Device Sequence Number: 4992843
• Product Code: PZK
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/19/2026

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: L08-006223
• Date Returned to Manufacturer: 12/03/2025
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/19/2025
• Supplement Date Received by Manufacturer: 05/26/2026
• Initial Report FDA Received Date: 12/17/2025
• Supplement Report FDA Received Date: 06/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/27/2024
• 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: 77 YR
• Patient Sex: Female