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

Model Number	60007
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Visual Disturbances (2140)
Date of Event	04/22/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
A site reported to rxsight that a patient with the light adjustable lens+ (lal+, sn (b)(6), +18.0d) completed two light treatments and did not undergo lock-in light treatments.Approximately 14 months after implantation, the patient's lal+ was explanted due to visual disturbances associated with observations that are consistent with zone formation.A new lal was 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
Additional data: h3.The explanted lens was returned for evaluation.Visual inspection of the returned lens was conducted and a large central bump was observed on the lens optic.The lens was also evaluated under an interferometer.The center of the lens optic was noted to be blurry due to the central bump on the lens.This blurriness is evident of uncontrolled polymerization of the lens.

• 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: 22063334
• Report Number: 3012712027-2025-00128
• Device Sequence Number: 18105307
• Product Code: PZK
• UDI-Device Identifier: 00818806021545
• UDI-Public: 01008188060215451123111817261031
• 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): 09/23/2025

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: L08-005484
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/22/2025
• Supplement Date Received by Manufacturer: 08/26/2025
• Initial Report FDA Received Date: 05/21/2025
• Supplement Report FDA Received Date: 09/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/18/2023
• 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: 82 YR
• Patient Sex: Male