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 Disturbances (2140)
Date of Event	03/27/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The site reported that a light adjustable lens (lal sn (b)(6), +16.0d) was explanted on (b)(6) 2023 and a new lal was implanted.Rxsight's first awareness of this event was on (b)(6) 2023.
Additional Manufacturer Narrative
The device history record for the manufacturing lot was reviewed and there were no discrepancies or unusual findings.The implant surgery for this patient's right eye (od) was on (b)(6) 2022.The patient's light adjustment treatments were uneventful.The lock-in #1 treatment was performed on (b)(6) 2023.The patient started to report ghosting in their right eye on (b)(6) 2023.The patient's vision after the final lock-in visit was ucdva 20/20, mr +0.25 sphere, and bcdva 20/20.However, the patient's report of ghosting persisted, and the treating physician eventually opted to explant the lal (sn (b)(6)) and replace it with another lal on (b)(6) 2023.Manufacturer reference #:(b)(4).
Additional Manufacturer Narrative
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: 16820060
• Report Number: 3012712027-2023-00031
• Device Sequence Number: 17916311
• Product Code: PZK
• UDI-Device Identifier: 00818806020821
• UDI-Public: 01008188060208211121091817240831
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: P160055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/01/2023

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: 08/31/2024
• Device Model Number: 60005
• Device Catalogue Number: 60005
• Device Lot Number: L07-003447
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/27/2023
• Supplement Date Received by Manufacturer: 03/27/2023
• Initial Report FDA Received Date: 04/26/2023
• Supplement Report FDA Received Date: 12/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/18/2021
• 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: 52 YR
• Patient Sex: Male
• Patient Race: White