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

Model Number	60005
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Visual Impairment (2138)
Date of Event	09/20/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The site reported that a bilaterally implanted patient had a light adjustable lens (lal, sn (b)(6)) explanted from her right eye (od).Another lal was implanted as replacement.Rxsight's first awareness of this event was on 09/20/2023.
Additional Manufacturer Narrative
The treating physician reported that after the initial cataract surgery on (b)(6) 2023 (right eye, od) and (b)(6) 2023 (left eye, os), the patient had corneal edema and dendrites observed on the cornea.The patient's corneal issues were fully resolved by (b)(6) 2023.Manifest refraction (mr) and best-corrected visual acuity (bcva) for the right eye were plano +0.75 x092 and 20/50, respectively.During the following visit on (b)(6) 2023, the right eye received the first light treatment.The treating physician reported that the treatment target was achieved but the patient showed no improvement in visual acuity (va).The patient's mr and bcva for the right eye on (b)(6) 2023 were plano +0.25 x080 and 20/30, respectively.The treating physician eventually decided to proceed with a lens replacement for the right eye.The od lens was replaced with another lal on (b)(6) 2023.The device history record for the manufacturing lot was reviewed and there were no discrepancies or unusual findings.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: 17966271
• Report Number: 3012712027-2023-00088
• Device Sequence Number: 7820551
• Product Code: PZK
• UDI-Device Identifier: 00818806020746
• UDI-Public: 01008188060207461122022717250131
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P160055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• 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): 10/19/2023

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 Expiration Date: 01/31/2025
• Device Model Number: 60005
• Device Catalogue Number: 60005
• Device Lot Number: L07-003714
• 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: 09/20/2023
• Initial Report FDA Received Date: 10/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/27/2022
• 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 Sex: Female