MAUDE Adverse Event Report: RxSight Inc. Light Adjustable Lens (LAL)

Model Number	60005
Medical Device Problem Code	Optical Decentration (1360)
Health Effect - Clinical Code	Unspecified Eye / Vision Problem (4471)
Date of Event	08/17/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
A site reported to rxsight that a patient's light adjustable lens (lal) was observed to be dislocated during a post-operative exam.An anterior vitrectomy was performed and the lal was successfully repositioned in the sulcus during a secondary surgery.
Additional Manufacturer Narrative
The device history record for the manufacturing lot was reviewed and there were no discrepancies or unusual findings.Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.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 ; +1(949)273-6163
• MDR Report Key: 50820389
• Report Number: 3012712027-2026-00407
• Device Sequence Number: 21494830
• Product Code: PZK
• UDI-Device Identifier: 00818806020685
• UDI-Public: (01)00818806020685(11)250405(17)280331
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: P160055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted 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): 09/18/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 60005
• Device Catalogue Number: 60005
• Device Lot Number: L07-008432
• 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: 08/24/2026
• Initial Report FDA Received Date: 09/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/05/2025
• 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: 82 YR
• Patient Sex: Male