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	10/06/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Site reported the light adjustable lens was explanted as the desired refractive outcome was not achieved after light adjustment treatments.Rxsight's first awareness of the event was 10/14/2021.Device history record for the lens was reviewed.No issues were noted.The explanted lens was returned and is currently being evaluated.
Event or Problem Description
Site reported the light adjustable lens was explanted as the desired refractive outcome was not achieved after light adjustment treatments.Rxsight's first awareness of the event was 10/14/2021.
Additional Manufacturer Narrative
Site reported the light adjustable lens was explanted as the desired refractive outcome was not achieved after light adjustment treatments.Rxsight's first awareness of the event was (b)(6) 2021.The explanted lens was returned for evaluation.Visual inspection and optical testing of the returned lens confirmed the presence of an ambient zone on the lens, indicative of exposure of the lens to ambient uv light prior to lock in.
Event or Problem Description
Site reported the light adjustable lens was explanted as the desired refractive outcome was not achieved after light adjustment treatments.Rxsight's first awareness of the event was (b)(6) 2021.

• Brand Name: LIGHT ADJUSTABLE LENS (LAL)
• Common Device Name: LIGHT ADJUSTABLE LENS
• Manufacturer (Section D): RXSIGHT, INC.; 100 columbia; aliso viejo CA 92656
• Manufacturer (Section G): RXSIGHT, INC.; 100 columbia; aliso viejo CA 92656
• Manufacturer Contact: kelli carrillo ; 100 columbia; aliso viejo 92656
• MDR Report Key: 12782948
• Report Number: 3012712027-2021-00071
• Device Sequence Number: 17070918
• Product Code: PZK
• UDI-Device Identifier: 00818806020197
• UDI-Public: 01008188060201971120011217221231
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/09/2021

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: 12/31/2022
• Device Model Number: 60005
• Device Catalogue Number: 60005
• Device Lot Number: L02-001498
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/21/2021
• Supplement Date Received by Manufacturer: 10/21/2021
• Initial Report FDA Received Date: 11/09/2021
• Supplement Report FDA Received Date: 12/20/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/12/2020
• 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