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 Codes	Blurred Vision (2137); Visual Disturbances (2140)
Date of Event	07/22/2024
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 site reported to rxsight that a bilaterally implanted patient had a light adjustable lens+ (lal+, sn (b)(6), +20.5d) explanted from the right eye due to possible visual changes after use of a tanning bed without rxsight uv protective spectacles prior to any light treatments being performed.Examination of fragments of the lens returned to rxsight after explantation did not reveal obvious signs of abnormal polymerization.A new lal (sn (b)(6), +21.0d) was implanted as a replacement.Rxsight's first awareness of this event was on 07/22/2024.Reference report #3012712027-2024-00078 for the report on the left eye.

• 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: 20033324
• Report Number: 3012712027-2024-00131
• Device Sequence Number: 19582726
• Product Code: PZK
• UDI-Device Identifier: 00818806021590
• UDI-Public: 01008188060215901123112917261031
• 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: 2024
• Device Explanted Year: 2024
• 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): 08/21/2024

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: L08-005546
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/22/2024
• Initial Report FDA Received Date: 08/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/29/2023
• 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: 78 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White