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	Blurred Vision (2137)
Date of Event	05/08/2024
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 bilaterally implanted patient's light adjustable lens (lal, sn (b)(6), +26.0d) was implanted in the patient's right eye (od) on (b)(6) 2023.The patient completed one light adjustment treatment during the postoperative period.The patient did not complete the required lock-in light treatments.On (b)(6) 2024, approximately 10 months after the implant surgery, the lal was explanted from the patient's right eye.A new light adjustable lens was implanted as a replacement.Rxsight's first awareness of this event was on 05/08/2024.Reference report #3012712027-2024-00092 for the report on the left eye (os).
Additional Manufacturer Narrative
The lal was cut into fragments during explantation.Visual inspection on the returned lens fragments found no device related issues.Due to the condition of the lens, further evaluation could not be performed.Section h6 codes were updated accordingly.A correction was made to the investigation findings code, the code 4248 was removed.Manufacturer reference #: (b)(4).

• 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: 19454576
• Report Number: 3012712027-2024-00091
• Device Sequence Number: 8538414
• Product Code: PZK
• UDI-Device Identifier: 00818806020777
• UDI-Public: 01008188060207771121111317241031
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: P160055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• 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): 03/28/2025

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: 10/31/2024
• Device Model Number: 60005
• Device Catalogue Number: 60005
• Device Lot Number: L07-003547
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/16/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/08/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/03/2024
• Supplement Report FDA Received Date: 03/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/13/2021
• 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: 52 YR
• Patient Sex: Female