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)
Type of Reportable Event	Malfunction
Event or Problem Description
A site reported to rxsight that a light adjustable lens (lal, sn (b)(6), +23.5d) was implanted backwards.
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: 22079818
• Report Number: 3012712027-2025-00131
• Device Sequence Number: 15628915
• Product Code: MSS
• UDI-Device Identifier: 00818806020746
• UDI-Public: 01008188060207461123041517260331
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/23/2025

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: 04/25/2025
• Initial Report FDA Received Date: 05/23/2025
• 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: Initial
• Patient Sequence Number: 1
• Patient Age: 75 YR
• Patient Sex: Female