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

Model Number	60005
Medical Device Problem Codes	Use of Device Problem (1670); Optical Problem (3001)
Health Effect - Clinical Codes	Blurred Vision (2137); Visual Disturbances (2140)
Date of Event	06/02/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
A site reported to rxsight that a patient's light adjustable lens (lal) was explanted due to decreased vision after three light adjustments and no lock-in treatments; another lal was implanted as a replacement.The decreased vision reportedly began during a hospitalization for pneumonia and was characterized by blurred distance vision and ghosting while driving.The patient also reported to the site a history of tanning bed use.
Additional Manufacturer Narrative
Manufacturing records were reviewed and found no deviations, non-conformance's, or other manufacturing issues related to the reported event.The explanted conformance's was cut into small fragments during explantation and returned to rxsight.Due to the condition of the lens, an evaluation could not be performed.A definitive root cause for the reported event could not be established.Reported prior hospitalization and tanning bed use may have been contributing factors.Per the ifu, "if the implanted eye is exposed to uv light without the use of uv protective eyewear before 24 hours post final lock-in treatment, the lal can change unpredictably, causing aberrated optics and blurred vision, which might necessitate explantation of the lal." 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 ; 9492736163
• MDR Report Key: 25681657
• Report Number: 3012712027-2026-00298
• Device Sequence Number: 4670588
• Product Code: PZK
• UDI-Device Identifier: 00818806020753
• UDI-Public: (01)00818806020753(11)250629(17)280531
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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: 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): 07/01/2026

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: L07-008800
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/02/2026
• Initial Report FDA Received Date: 07/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/29/2025
• 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
• Patient Age: 54 YR
• Patient Sex: Female