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

Model Number	60005
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Blurred Vision (2137)
Date of Event	05/20/2025
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 site reported to rxsight that a light adjustable lens (lal, sn (b)(6), +20.5d) was implanted on (b)(6) 2024.Postoperatively, the patient was exposed to uv light from a tanning bed prior to starting light treatments.The patient reported blurry distance vision immediately after exposure and continued to report blurry distance vision after completing one light treatment.The lal was explanted on (b)(6) 2025 and a new lal (sn (b)(6), +25.0d) was implanted as a replacement.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide additional information to the following sections: d9, h3, h6, and h11.The lal was cut into two main pieces during explantation and both haptics were detached from the lens optic with one haptic completely missing.No device problem was found during visual inspection.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: 22215808
• Report Number: 3012712027-2025-00161
• Device Sequence Number: 20997516
• Product Code: PZK
• UDI-Device Identifier: 00818806020685
• UDI-Public: 01008188060206851122111817251031
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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: 2025
• 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): 02/11/2026

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: 10/31/2025
• Device Model Number: 60005
• Device Catalogue Number: 60005
• Device Lot Number: L07-004400
• 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: 05/20/2025
• Supplement Date Received by Manufacturer: 01/12/2026
• Initial Report FDA Received Date: 06/16/2025
• Supplement Report FDA Received Date: 02/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/18/2022
• 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: Female