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	10/15/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Site reported that a light adjustable lens was explanted from the patient as the patient was experiencing double vision.Rxsight's first awareness of the event was (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.
Event or Problem Description
Site reported that a light adjustable lens was explanted from the patient as the patient was experiencing double vision.Rxsight's first awareness of the event was (b)(6) 2021.
Event or Problem Description
Site reported that a light adjustable lens was explanted from the patient as the patient was experiencing double vision.Rxsight's first awareness of the event was 12/1/2021.
Additional Manufacturer Narrative
Site reported that a light adjustable lens was explanted from the patient as the patient was experiencing double vision.Rxsight's first awareness of the event was 12/1/2021.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, which is indicative of exposure of the lens to ambient uv light prior to lock in.

• 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: 13049052
• Report Number: 3012712027-2021-00086
• Device Sequence Number: 1427700
• Product Code: PZK
• UDI-Device Identifier: 00818806020258
• UDI-Public: 01008188060202581120060717230531
• 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 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): 12/15/2021

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: 05/31/2023
• Device Model Number: 60005
• Device Catalogue Number: 60005
• Device Lot Number: L02-001664
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/01/2021
• Supplement Date Received by Manufacturer: 12/01/2021
• Initial Report FDA Received Date: 12/20/2021
• Supplement Report FDA Received Date: 02/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/07/2020
• 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