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	Visual Impairment (2138)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A physician reported to a rxsight field representative that a patient presented in the clinic complaining of decreased vision in the right eye on (b)(6) 2023.The patient had undergone implantation of the lal on (b)(6) 2022 and had a single treatment with the light delivery device (ldd) treatment on (b)(6) 2022.However, the lock-in treatments were not performed and the patient reported that they had been driving a semi-truck across the united states for the past 18 months prior to the recent clinic visit.They also reported wearing their personal sunglasses instead of approved rxsight uv protective eyewear.Upon examining the patient's lal on (b)(6) 23, the physician noted reduced best corrected vision, anterior haze and higher order aberrations." the lal was explanted.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 user facility reported to rxsight that a light adjustable lens (lal, sn (b)(6), +23.5d) was explanted.Rxsight's first awareness of the lal explantation event was on (b)(6) 2023.

• Brand Name: LIGHT ADJUSTABLE LENS (LAL)
• Common Device Name: LIGHT ADJUSTABLE LENS (LAL)
• Manufacturer (Section D): RXSIGHT, INC.; 100 columbia; aliso viejo 92656
• Manufacturer (Section G): RXSIGHT, INC.; 100 columbia; aliso viejo CA 92656
• Manufacturer Contact: jim zhang ; 100 columbia; aliso viejo 92656 ; 9492736163
• MDR Report Key: 18040628
• Report Number: 3012712027-2023-00095
• Device Sequence Number: 7287882
• Product Code: PZK
• UDI-Device Identifier: 00818806020746
• UDI-Public: 01008188060207461121081517240731
• 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: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/31/2023

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: 07/31/2024
• Device Model Number: 60005
• Device Catalogue Number: 60005
• Device Lot Number: L07-003373
• 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: 10/05/2023
• Initial Report FDA Received Date: 10/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/15/2021
• 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: 74 YR
• Patient Sex: Male