MAUDE Adverse Event Report: RXSIGHT INC. RXSIGHT INSERTION DEVICE

Model Number	63001
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Capsular Bag Tear (2639)
Date of Event	06/23/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.Manufacturer reference #: 17231.
Event or Problem Description
A site reported that, during implantation of a light adjustable lens (lal), the lens was inadvertently implanted backwards.The surgeon was able to flip the lal to the correct orientation; however, a capsular bag tear occurred.A vitrectomy was performed, and the lal was subsequently implanted in the sulcus.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: 25893547
• Report Number: 3012712027-2026-00323
• Device Sequence Number: 18666724
• Product Code: MSS
• UDI-Device Identifier: 00818806020005
• UDI-Public: 00818806020005
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 07/21/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 63001
• Device Catalogue Number: 63001
• 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: 06/23/2026
• Initial Report FDA Received Date: 07/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 60005-LIGHT ADJUSTABLE LENS (LAL), SN (B)(6)
• Outcome Attributed to Adverse Event: Disability
• Patient Age: 69 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White