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

Model Number	60005
Medical Device Problem Code	Optical Problem (3001)
Health Effect - Clinical Code	Visual Impairment (2138)
Date of Event	07/13/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Site reported the light adjustable lens was explanted as the patient changed their desired refractive outcome after lock-in.Rxsight's first awareness of this event was (b)(6) 2022.
Additional Manufacturer Narrative
Site reported the light adjustable lens was explanted as the patient changed their desired refractive outcome after lock-in.Rxsight's first awareness of this event was (b)(6) 2022.Device history record for the lens was reviewed.No issues were noted.The explanted lens was returned and currently undergoing evaluation.

• 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: steven tran ; 100 columbia; aliso viejo, CA 92656
• MDR Report Key: 15214420
• Report Number: 3012712027-2022-00032
• Device Sequence Number: 12265383
• Product Code: PZK
• UDI-Device Identifier: 00818806020593
• UDI-Public: 01008188060205931121101817240930
• 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 Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/11/2022

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 Expiration Date: 09/30/2024
• Device Model Number: 60005
• Device Catalogue Number: 60005
• Device Lot Number: L07-003496
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/26/2022
• Initial Report FDA Received Date: 08/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/18/2021
• 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 Sex: Unknown