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	07/07/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Site reported the light adjustable lens was explanted from the patient's eye as the patient did not return for any light adjustment treatments.Another lal was implanted during the exchange on (b)(6) 2021.Rxsight's first awareness of the event occurred on (b)(6) 2021.
Additional Manufacturer Narrative
Site reported the light adjustable lens was explanted from the patient's eye as the patient did not return for any light adjustment treatments.Another lal was implanted during the exchange on (b)(6) 2021.Rxsight's first awareness of the event occurred on (b)(6) 2021.Device history record for the lens was reviewed.No issues were noted.The lens is in the process of being returned for evaluation.
Additional Manufacturer Narrative
Site reported the light adjustable lens was explanted from the patient's eye as the patient did not return for any light adjustment treatments.Another lal was implanted during the exchange on (b)(6) 2021.Rxsight's first awareness of the event occurred on 12/1/2021.The explanted lens was returned for evaluation.Visual and optical testing verified the presence of a zone near the center of the lens.The presence of the zone is indicative of lens exposure to ambient uv light.
Event or Problem Description
Site reported the light adjustable lens was explanted from the patient's eye as the patient did not return for any light adjustment treatments.Another lal was implanted during the exchange on (b)(6) 2021.Rxsight's first awareness of the event occurred on 12/1/2021.

• 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, CA 92656
• MDR Report Key: 12969830
• Report Number: 3012712027-2021-00082
• Device Sequence Number: 4573471
• Product Code: PZK
• UDI-Device Identifier: 00818806020234
• UDI-Public: 010081880602023417221031
• 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 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): 12/08/2021

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: 10/31/2022
• Device Model Number: 60005
• Device Catalogue Number: 60005
• Device Lot Number: L02-001398
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/01/2021
• Supplement Date Received by Manufacturer: 12/01/2021
• Initial Report FDA Received Date: 12/09/2021
• Supplement Report FDA Received Date: 12/30/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/07/2019
• 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: Female