MAUDE Adverse Event Report: RXSIGHT, INC. LIGHT ADJUSTABLE LENS (LAL)

Model Number	60005
Medical Device Problem Codes	Optical Decentration (1360); Material Twisted/Bent (2981)
Health Effect - Clinical Code	Unspecified Eye / Vision Problem (4471)
Date of Event	03/23/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device history record for the manufacturing lot was reviewed and there were no discrepancies or unusual findings.Manufacturer reference #: (b)(4).
Event or Problem Description
A site reported to rxsight that a patient underwent primary cataract surgery during which a light adjustable lens (lal) was implanted.Approximately three weeks following the initial implantation, the lal was explanted due to lens dislocation, reportedly resulting from a bent haptic.A new lal was subsequently implanted as a replacement.Postoperatively, the lens was reported to be centered in the sulcus.Separately, and not related to an rxsight device, the site reported that a capsular tear occurred during the primary cataract surgery.An additional surgical procedure was performed approximately one week after the primary cataract surgery to complete a vitrectomy with removal of lens fragments.The reporter did not indicate whether the capsular tear or subsequent vitrectomy contributed to the reported lens dislocation.

• 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 ; 9492736163
• MDR Report Key: 24989594
• Report Number: 3012712027-2026-00188
• Device Sequence Number: 9642608
• Product Code: PZK
• UDI-Device Identifier: 00818806020623
• UDI-Public: (01)00818806020623(11)250623(17)280531
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P160055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• 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): 04/24/2026

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: L07-008764
• 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: 03/27/2026
• Initial Report FDA Received Date: 04/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/23/2025
• 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: 67 YR
• Patient Sex: Male