MAUDE Adverse Event Report: RXSIGHT, INC. LIGHT ADJUSTABLE LENS (LAL)

Model Number	60005
Medical Device Problem Code	Optical Decentration (1360)
Health Effect - Clinical Codes	Capsular Bag Tear (2639); Unspecified Eye / Vision Problem (4471)
Date of Event	12/11/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device history record for the manufacturing lot was reviewed and there were no discrepancies or unusual findings.Manufacturer reference #: (b)(4).
Event or Problem Description
A site reported to rxsight that a posterior capsule tear occurred during implantation of the light adjustable lens (lal, sn (b)(6), +21.5d) in the capsular bag on (b)(6) 2025.The surgeon elected to leave the lens in the capsular bag.During a postoperative examination on (b)(6) 2025, the lens was observed to be dislocated.On (b)(6) 2025, a secondary procedure was attempted to reposition the lens into the ciliary sulcus.During the procedure to reposition the lens, the haptic broke.The lens was explanted, a vitrectomy was performed, and another lal (sn (b)(6), +22.5d) was implanted in the sulcus as a replacement.During a postoperative exam, the treating physician noted that the patient's intraocular pressure was elevated and the lal had dislocated again.Subsequently, the patient was scheduled for the yamane procedure to reposition the lens.
Additional Manufacturer Narrative
This supplemental report is submitted to provide additional information.Updates to sections b5 and h6.
Event or Problem Description
An additional procedure was successfully performed to reposition the lens via the yamane technique.

• Brand Name: LIGHT ADJUSTABLE LENS (LAL)
• Common Device Name: LIGHT ADJUSTABLE LENS (LAL)
• 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: 24067261
• Report Number: 3012712027-2026-00011
• Device Sequence Number: 10386477
• Product Code: PZK
• UDI-Device Identifier: 00818806020708
• UDI-Public: 01008188060207081125081517280731
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: P160055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/31/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: 60005
• Device Catalogue Number: 60005
• Device Lot Number: L07-008983
• 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: 12/15/2025
• Supplement Date Received by Manufacturer: 03/02/2026
• Initial Report FDA Received Date: 01/14/2026
• Supplement Report FDA Received Date: 03/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/15/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Disability
• Patient Sex: Female