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 Codes	Visual Impairment (2138); Diplopia/Double Vision (4802)
Date of Event	07/31/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
A site reported to rxsight that a bilaterally implanted patient's light adjustable lens was explanted from the left eye due to a shift in refraction and monocular diplopia after completion of light treatments.A new lal was implanted as a replacement.No additional information is available.
Additional Manufacturer Narrative
Manufacturing records were reviewed and found no deviations, non-conformances, or other manufacturing issues related to the reported event.A review of light delivery device data revealed that the final lock-in light treatment was delivered to an inadequately dilated eye, which could have contributed to the patient's symptoms.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: 50212626
• Report Number: 3012712027-2026-00379
• Device Sequence Number: 9915667
• Product Code: PZK
• UDI-Device Identifier: 00818806020685
• UDI-Public: (01)00818806020685(11)230821(17)260731
• 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: 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): 08/11/2026

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: 07/31/2026
• Device Model Number: 60005
• Device Catalogue Number: 60005
• Device Lot Number: L07-005100
• 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: 07/31/2026
• Initial Report FDA Received Date: 08/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/21/2023
• 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 Sex: Female