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

Model Number	60005
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Visual Impairment (2138)
Date of Event	08/24/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The site reported that a light adjustable lens had been explanted from the patient's right eye as the desired refractive outcome was not achieved after light adjustment treatments.Rxsight's first awareness of this was 8/26/2021.The device history record for the lens was reviewed.No issues were noted.The lens is currently in process of being returned for evaluation.
Event or Problem Description
The site reported that a light adjustable lens had been explanted from the patient's right eye as the desired refractive outcome was not achieved after light adjustment treatments.Rxsight's first awareness of this was 8/26/2021.
Event or Problem Description
The site reported that a light adjustable lens had been explanted from the patient's right eye as the desired refractive outcome was not achieved after light adjustment treatments.Rxsight's first awareness of this was 8/26/2021.
Additional Manufacturer Narrative
The site reported that a light adjustable lens had been explanted from the patient's right eye as the desired refractive outcome was not achieved after light adjustment treatments.Rxsight's first awareness of this was 8/26/2021.The explanted lens was returned for evaluation.The lens was cut into multiple fragments.Visual and optical testing found no issues with the lens.Corrected udi: (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: yi young ; 100 columbia; aliso viejo, CA 92656
• MDR Report Key: 12510863
• Report Number: 3012712027-2021-00055
• Device Sequence Number: 5122325
• Product Code: PZK
• UDI-Device Identifier: 00818806020210
• UDI-Public: 01008188060202101119120417221130
• 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: 2020
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 09/21/2021

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: 11/30/2022
• Device Model Number: 60005
• Device Catalogue Number: 60005
• Device Lot Number: L02-001446
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/26/2021
• Supplement Date Received by Manufacturer: 08/26/2021
• Initial Report FDA Received Date: 09/21/2021
• Supplement Report FDA Received Date: 12/03/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/04/2019
• 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: Male