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	Visual Disturbances (2140)
Date of Event	04/21/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturing records were reviewed and found no deviations, non-conformances, or other manufacturing issues related to the reported event.Manufacturer reference #: (b)(4).
Event or Problem Description
A site reported to rxsight that a patient implanted with light adjustable lens (lal) in the left eye underwent a secondary procedure after all light treatments to implant a non-rxsight sulcus-fixated lens to correct residual refractive error and blurry vision.Postoperatively, the patient complained of blurry vision, light sensitivity, and visual disturbances in the setting of a dilated pupil.The sulcus-fixated lens was also observed to be decentered and was later repositioned.The patient's visual disturbances persisted secondary to pupillary issues despite attempted treatment.Following this, the lal was explanted.

• 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: 25250411
• Report Number: 3012712027-2026-00220
• Device Sequence Number: 9724834
• Product Code: PZK
• UDI-Device Identifier: 00818806020661
• UDI-Public: (01)00818806020661(11)230329(17)260228
• 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: 2023
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/21/2026

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: 02/28/2026
• Device Model Number: 60005
• Device Catalogue Number: 60005
• Device Lot Number: L07-004689
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/29/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/21/2026
• Initial Report FDA Received Date: 05/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/29/2023
• 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: 75 YR
• Patient Sex: Female