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

Model Number	60005
Medical Device Problem Code	Optical Problem (3001)
Health Effect - Clinical Code	Unspecified Eye / Vision Problem (4471)
Date of Event	08/19/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
A site reported to rxsight that after a patient's light adjustable lens (lal) was implanted, the patient underwent 3 light adjustments and 1 lock-in treatment postoperatively.The patient returned to the clinic approximately 3 years after implantation and a slit lamp exam found evidence of a suspected central distortion that is consistent with photopolymerization.A fourth light adjustment and second lock-in were then performed.The lal was subsequently explanted and a vitrectomy was performed before a new lal was implanted as a replacement.
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: 50790249
• Report Number: 3012712027-2026-00397
• Device Sequence Number: 21224974
• Product Code: PZK
• UDI-Device Identifier: 00818806020654
• UDI-Public: (01)00818806020654(11)221017(17)250930
• 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: 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): 09/16/2026

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: 09/30/2025
• Device Model Number: 60005
• Device Catalogue Number: 60005
• Device Lot Number: L07-004324
• 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: 08/19/2026
• Initial Report FDA Received Date: 09/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/17/2022
• 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): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male