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

Model Number	60005
Medical Device Problem Code	Optical Problem (3001)
Health Effect - Clinical Code	Blurred Vision (2137)
Type of Reportable Event	Serious Injury
Event or Problem Description
A site reported to rxsight that a patient was bilaterally implanted with pre-activshield light adjustable lenses (lals) and subsequently underwent one light adjustment treatment and one lock-in treatment in the right eye.Approximately 38 months later, the patient presented to a different clinic reporting blurry vision in the right eye.Upon examination, the right eye lal was observed to have a dome-shaped finding on the anterior surface of the lens; however, the finding was not noted as significant, and a piggyback intraocular lens (iol) was implanted to address the patient's blurry vision associated with residual hyperopia.Approximately 19 months after this procedure, the patient again reported blurry vision, and the right eye lal was noted to exhibit a prominent dome-shaped zone.The surgeon indicated plans to explant the right eye lal; however, it is unknown whether the explant procedure has been scheduled or performed.No additional information has been provided.
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: 50193885
• Report Number: 3012712027-2026-00375
• Device Sequence Number: 21311101
• Product Code: PZK
• UDI-Device Identifier: 00818806020210
• UDI-Public: (01)00818806020210(11)191207(17)221130
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: P160055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• 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): 08/10/2026

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 Expiration Date: 11/30/2022
• Device Model Number: 60005
• Device Catalogue Number: 60005
• Device Lot Number: L02-001452
• 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: 07/13/2026
• Initial Report FDA Received Date: 08/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/07/2019
• 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