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 Disturbances (2140)
Date of Event	04/26/2026
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
The site reported that following completion of light adjustment treatments, the patient experienced minimal change in refraction and complained of glare and halos in the left eye.Upon examination, the implanted light adjustable lens (lal) was observed to be implanted backwards.The site reported that the patient was satisfied with their vision and there is no surgical intervention planned.No additional information has been provided.

• 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: 25814696
• Report Number: 3012712027-2026-00329
• Device Sequence Number: 13421017
• Product Code: MSS
• UDI-Device Identifier: 10818806021016
• UDI-Public: 10818806021016
• Combination Product (Y/N): N
• Initial Reporter State: WV
• 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): 07/14/2026

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
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/19/2026
• Initial Report FDA Received Date: 07/14/2026
• 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: 60005-LIGHT ADJUSTABLE LENS (LAL) , (b)(6).; 60005-LIGHT ADJUSTABLE LENS (LAL), (B)(6).
• Patient Age: 68 YR
• Patient Sex: Female