MAUDE Adverse Event Report: RxSight, Inc. Light Adjustable Lens (LAL)

Model Number	60005
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Corneal Edema (1791); Capsular Bag Tear (2639); Corneal Endothelial Cell Loss (4806)
Date of Event	08/24/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
A site reported to rxsight that upon implantation of a light adjustable lens (lal), it was noted the leading haptic had become severed.While attempting to remove the lal, both haptics detached from the optic, resulting in the surgeon using intraocular scissors to section the lens to facilitate removal.A posterior capsular tear occurred during lens removal, requiring a vitrectomy.A replacement lal was subsequently implanted successfully in the sulcus.Although a dispersive ovd was used intraoperatively to protect the corneal endothelium, the surgeon reported at the two-week postoperative visit that significant corneal edema persisted and expressed concern that endothelial compromise had occurred, potentially requiring future endothelial transplantation.
Additional Manufacturer Narrative
Manufacturing records were reviewed and found no deviations, non-conformance, or other manufacturing issues related to the reported event.Manufacturer reference#: (b)(4).

• 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 ; +1(949)273-6163
• MDR Report Key: 50868490
• Report Number: 3012712027-2026-00412
• Device Sequence Number: 13106369
• Product Code: PZK
• UDI-Device Identifier: 00818806020609
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: P160055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• 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): 09/23/2026

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: 60005
• Device Catalogue Number: 60005
• Device Lot Number: L07-009236
• 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: 08/28/2026
• Initial Report FDA Received Date: 09/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/02/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: Single-Use Injector, Lot Number: A03-2138.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male