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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/14/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A sight reported to rxsight that a patient's light adjustable lens (lal) was delivered backwards in the patient's eye.During the implantation procedure, the patient communicated that they were in distress/pain, reportedly related to the patient clamping and occluding the pain medication line.The physician did not remove or flip the lens to the correct orientation in order to avoid further patient discomfort and due to the patient's shallow capsular bag and the possible risk of a capsular bag rupture.
Additional Manufacturer Narrative
Manufacturing records were reviewed and found no deviations, non-conformances, or other manufacturing issues related to the reported event.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: 25491925
• Report Number: 3012712027-2026-00271
• Device Sequence Number: 21411292
• Product Code: MSS
• UDI-Device Identifier: 00818806021019
• UDI-Public: (01)00818806021019(17)270131(10)A03-2181
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/12/2026

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
• Device Lot Number: A03-2181
• 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: 05/14/2026
• Initial Report FDA Received Date: 06/12/2026
• 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, MODEL 60005.
• Patient Age: 78 YR
• Patient Sex: Female
• Patient Race: White