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 Code	Blurred Vision (2137)
Date of Event	11/06/2025
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 patient's light adjustable lens+ (lal+, sn: (b)(6), +21.0d) was explanted from the right eye due to blurry vision.A new lal (sn: (b)(6), +21.0d) was implanted as a replacement.
Event or Problem Description
A site reported to rxsight that a patient's light adjustable lens (lal) was explanted from the right eye due to blurry vision and being unable to tolerate anisometropia.A new lal was implanted as a replacement.
Additional Manufacturer Narrative
Additional data: a2, h3, h6 (type of investigation, investigation findings, investigation conclusions), h11.Corrected data: b5, h6 (component code).The explanted light adjustable lens (lal) was returned for evaluation.A visual inspection was performed and the lens was found to have been cut into two main pieces and one of the haptics was missing.No abnormalities were observed on the returned lens pieces, therefore, the most 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: 23706531
• Report Number: 3012712027-2025-00379
• Device Sequence Number: 10641374
• Product Code: PZK
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P160055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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): 05/29/2026

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 Model Number: 60007
• Device Catalogue Number: 60007
• Device Lot Number: L08-008064
• Date Returned to Manufacturer: 11/13/2025
• 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: 11/06/2025
• Supplement Date Received by Manufacturer: 04/28/2026
• Initial Report FDA Received Date: 12/03/2025
• Supplement Report FDA Received Date: 05/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/05/2025
• 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: 60 YR
• Patient Sex: Male