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

Model Number	60005
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/13/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
A site reported to rxsight that a light adjustable lens (lal, (b)(6), +19.0d) was explanted.A new lal (sn (b)(6), +19.5d) 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: h6 (type of investigation, investigation findings, investigation conclusions), h11 corrected data: h6 (component code) the explanted light adjustable lens (lal) was returned for evaluation; however, no additional evaluation was able to be performed.Based on the limited available information, the likely cause of the reported event could not be identified.

• 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 ; 9492736163-159
• MDR Report Key: 22510092
• Report Number: 3012712027-2025-00235
• Device Sequence Number: 9303472
• Product Code: PZK
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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: 2025
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/20/2026

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: 12/31/2025
• Device Model Number: 60005
• Device Catalogue Number: 60005
• Device Lot Number: L07-004511
• Date Returned to Manufacturer: 07/01/2025
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/17/2025
• Supplement Date Received by Manufacturer: 04/20/2026
• Initial Report FDA Received Date: 07/15/2025
• Supplement Report FDA Received Date: 05/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/20/2023
• 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 Sex: Unknown