MAUDE Adverse Event Report: RXSIGHT, INC. RXSIGHT INSERTION DEVICE

Model Number	63001
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/08/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A site reported to rxsight that upon insertion of a light adjustable lens (lal) the lens flipped to the wrong orientation and due to the patient's anterior chamber being too shallow, the lens could not be flipped to the correct orientation.The lal was exchanged for a new lal during the same procedure.No additional information was provided.
Additional Manufacturer Narrative
Manufacturer reference #: (b)(4).

• Brand Name: RXSIGHT INSERTION DEVICE
• Common Device Name: RXSIGHT INSERTION DEVICE
• 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: 25781800
• Report Number: 3012712027-2026-00311
• Device Sequence Number: 21234481
• Product Code: MSS
• UDI-Device Identifier: 00818806020005
• UDI-Public: 00818806020005
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K231466
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/10/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 63001
• Device Catalogue Number: 63001
• 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: 06/11/2026
• Initial Report FDA Received Date: 07/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 6005, LIGHT ADJUSTABLE LENS (LAL), (B)(6).
• Patient Sex: Unknown