MAUDE Adverse Event Report: RxSight, Inc. RxSight Insertion Device

Model Number	63002
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/10/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A site reported to rxsight that a patient's light adjustable lens (lal) was implanted backwards due to an error when loading the injector.The lens was removed from the eye and replaced with another lal during the same surgery.No additional information has been provided.
Additional Manufacturer Narrative
The instructions for use for the single-use injector provide explicit instructions for proper lens loading, including lens positioning/orientation, haptic placement, cartridge closure, lens advancement, and visual verification steps prior to implantation.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 ; +1(949)273-6163
• MDR Report Key: 50716743
• Report Number: 3012712027-2026-00390
• Device Sequence Number: 13278502
• Product Code: MSS
• UDI-Device Identifier: 10818806021016
• UDI-Public: 10818806021016
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/10/2026

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: 08/12/2026
• Initial Report FDA Received Date: 09/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: Light Adjustable Lens, Model 6005. SN 70103620330
• Patient Sex: Unknown