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

Model Number	60007
Medical Device Problem Code	Optical Decentration (1360)
Health Effect - Clinical Code	Visual Impairment (2138)
Date of Event	07/07/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
A site reported to rxsight that a bilaterally implanted patient underwent explantation of the light adjustable lens+ (lal+) in the right eye after two adjustments due to a decrease in visual acuity.Following the first adjustment, the lens was observed to be slightly decentered.The patient was reported to be doing well post-explant.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.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: 50159646
• Report Number: 3012712027-2026-00349
• Device Sequence Number: 9092336
• Product Code: PZK
• UDI-Device Identifier: 00818806021668
• UDI-Public: (01)00818806021668(11)241207(17)271130
• 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: 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,Followup
• Report Date (Section B): 09/29/2026

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: L08-007936
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/13/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/09/2026
• Supplement Date Received by Manufacturer: 09/28/2026
• Initial Report FDA Received Date: 08/06/2026
• Supplement Report FDA Received Date: 09/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/07/2024
• 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: Male