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

Model Number	60007
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Visual Impairment (2138)
Date of Event	07/26/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
A site reported to rxsight that a patient's light adjustable lens+ (lal+, (b)(6), +16.5d) was explanted due to the observation of an apparent slight annular obscuration on the lens and a new intraocular lens from a different manufacturer was implanted as a replacement.Rxsight's first awareness of the event was on 07/26/2024.
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 patient's light adjustable lens+ (lal+, sn (b)(6), +16.5d) was explanted due to decreased visual acuity.
Additional Manufacturer Narrative
Section b5 event description has been corrected based on investigation findings.Additional information based on investigation findings provided below: fragments of the explanted lal were returned to rxsight and based on visual inspection under magnification, the slight annular obscuration was confirmed.Based on the observed presentation and location of the obscuration, it is extremely unlikely to have caused or contributed to the patient's visual acuity decrease, as the treating physician reported that the patient's best corrected visual acuity was 20/20, then degraded to 20/40 after receiving light treatments.Section h6 codes were updated accordingly.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: 20058171
• Report Number: 3012712027-2024-00139
• Device Sequence Number: 7634941
• Product Code: PZK
• UDI-Device Identifier: 00818806021514
• UDI-Public: 01008188060215141123122717261130
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: P160055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• 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): 02/26/2025

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: 60007
• Device Catalogue Number: 60007
• Device Lot Number: L08-005692
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/26/2024
• Supplement Date Received by Manufacturer: 02/12/2025
• Initial Report FDA Received Date: 08/24/2024
• Supplement Report FDA Received Date: 02/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/27/2023
• 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: 58 YR
• Patient Sex: Female