MAUDE Adverse Event Report: RXSIGHT INC. RXSIGHT INSERTION DEVICE

Model Number	63002
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Visual Impairment (2138)
Date of Event	02/25/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.Manufacturer reference #: (b)(4).
Event or Problem Description
A site reported to rxsight that during a post-operative follow-up visit, a patient was found to have a light adjustable lens (lal) implanted in a backwards orientation in the right eye.The lal had been implanted during a procedure where a non-rxsight multifocal iol was exchanged for the lal; this procedure was reportedly difficult due to iris prolapse, poor dilation, and overall challenging intraoperative management, but the surgeon was ultimately able to implant the lal.Due to the intraoperative difficulties encountered during the exchange procedure, the surgeon does not want to explant or reposition the lal, considering surgical intervention to be too clinically risky.

• 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: 25393853
• Report Number: 3012712027-2026-00255
• Device Sequence Number: 12072329
• Product Code: MSS
• UDI-Device Identifier: 10818806021016
• UDI-Public: 10818806021016
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 06/04/2026

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: 63002
• Device Catalogue Number: 63002
• 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: 05/07/2026
• Initial Report FDA Received Date: 06/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Concomitant Medical Products and Therapy/Usage Dates: LIGHT ADJUSTABLE LENS (LAL), 60005 - SN (B)(6)
• Patient Age: 55 YR
• Patient Sex: Male