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

Model Number	60005
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Unspecified Eye / Vision Problem (4471)
Date of Event	05/13/2025
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 physician reported to rxsight that a patient was implanted with the light adjustable lens (lal, sn (b)(6), +20.0d).The patient had 2 light adjustments and no lock-in procedures.The patient presented to the clinic approximately 2 years after implantation complaining of a change in vision.The lal was explanted.Upon explantation of the lal, the surgeon noted a central circular bump present on the lens.
Additional Manufacturer Narrative
This supplemental report is submitted to provide the results of the device evaluation and provide a correction.Correction to section d9.Updates to sections g6, h3 and h6.The explanted lal was cut into fragments and returned to rxsight.A visual inspection confirmed an area consistent with zone formation due to uv exposure without completion of lock-in light treatments.Due to the condition of the lens fragments, additional analysis is not possible.

• 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: 22204130
• Report Number: 3012712027-2025-00154
• Device Sequence Number: 12673640
• Product Code: PZK
• UDI-Device Identifier: 00818806020678
• UDI-Public: 01008188060206781122070817250630
• 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 Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/15/2025

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 Expiration Date: 06/30/2025
• Device Model Number: 60005
• Device Catalogue Number: 60005
• Device Lot Number: L07-004092
• 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: 05/14/2025
• Supplement Date Received by Manufacturer: 07/18/2025
• Initial Report FDA Received Date: 06/13/2025
• Supplement Report FDA Received Date: 08/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/08/2022
• 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 Sex: Unknown