MAUDE Adverse Event Report: RXSIGHT INC. RXSIGHT INSERTION DEVICE

Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/27/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A site reported to rxsight that a patient experienced no refractive changes after a light adjustment.Upon examination, the lens was noted to be implanted backwards.Further light treatments have been postponed at this time.No additional information has been provided.
Additional Manufacturer Narrative
Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.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: 25623329
• Report Number: 3012712027-2026-00292
• Device Sequence Number: 21078726
• Product Code: MSS
• UDI-Device Identifier: 00818806020722
• UDI-Public: (01)00818806020722(11)250912(17)280831
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K231838
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 06/25/2026

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
• 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: 05/27/2026
• Initial Report FDA Received Date: 06/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/12/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 60005, LIGHT ADJUSTABLE LENS (LAL), SN (B)(4).
• Patient Sex: Unknown