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

Model Number	60005
Medical Device Problem Code	Optical Decentration (1360)
Health Effect - Clinical Code	Visual Disturbances (2140)
Date of Event	12/02/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
A patient's light adjustable lens (lal, sn (b)(6), +8.0d) was implanted (b)(6) 2025 during primary cataract surgery in the left eye with sulcus placement.Postoperatively, the lal was observed decentered and the patient complained of visual disturbances.The treating physician attributed the decentration of the lens to the "face down" position required of the patient during a procedure on (b)(6) 2025 to repair a retinal detachment in the right eye.A secondary surgical procedure was performed on (b)(6) 2025 to reposition the lens and perform an anterior vitrectomy.At the patient's postoperative exam, on (b)(6) 2025, the patient reported involvement in a car accident on (b)(6) 2025 and complained of glare/halos in the left eye.The patient continued to complain of visual disturbances in the left eye during the postoperative period and it was determined that the lens was decentered temporally.On (b)(6) 2025, an additional surgical procedure was performed to reposition the lens in the eye.
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).

• 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: 24849156
• Report Number: 3012712027-2026-00203
• Device Sequence Number: 21094221
• Product Code: PZK
• UDI-Device Identifier: 00818806020937
• UDI-Public: 01008188060209371125051417280430
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P160055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted 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): 06/24/2026

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: 60005
• Device Catalogue Number: 60005
• Device Lot Number: L07-008601
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/05/2026
• Supplement Date Received by Manufacturer: 05/26/2026
• Initial Report FDA Received Date: 04/11/2026
• Supplement Report FDA Received Date: 06/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/14/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 58 YR
• Patient Sex: Male