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

Model Number	60005
Medical Device Problem Code	Optical Distortion (3000)
Health Effect - Clinical Code	Visual Impairment (2138)
Date of Event	08/03/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Site reported the patient had bilateral light adjustable lenses implantation.Left eye (os) was implanted on (b)(6) 2021.Right eye (od) was implanted on (b)(6) 2021.Patient proceeded to have their 1st light treatment.After the 1st light treatment, for a prolonged period of time the patient was unable to return to the clinic for required follow-up light treatments due to unrelated illness and hospitalization.Patient returned to the clinic on (b)(6) 2022 and complained of blurry vision.Upon further examination, the treating physician opted to perform an exchange.The light adjustable lense for the left eye (os) is planned to be explanted.Rxsight's first awareness of the event was on (b)(6) 2022.
Additional Manufacturer Narrative
Given the prolonged period (8 months) without required light treatment to lock the implanted light adjustable lense in, it is highly likely that the lens was exposed to unintended ambient uv light during that time.Effects of ambient uv exposure prior to lock-in is an ambient zone on the lens which is highly consistent with the treating physician's decision.The light adjustable lense for the left eye (os) remains implanted at this time.The lens is planned to be explanted.Further evaluation of the lens will be conducted upon rxsight receiving the lens.

• 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
• MDR Report Key: 15353188
• Report Number: 3012712027-2022-00037
• Device Sequence Number: 20334185
• Product Code: PZK
• UDI-Device Identifier: 00818806020241
• UDI-Public: 01008188060202411120020417230131
• 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: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/02/2022

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: L02-001550
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/04/2022
• Initial Report FDA Received Date: 09/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Unknown