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	07/14/2021
Type of Reportable Event	Serious Injury
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.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 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.Visual inspection of the returned lens found the lens had been cut into multiple fragments.Visual inspection and optical testing of the lens found no issues with the lens.

• Brand Name: LIGHT ADJUSTABLE LENS (LAL)
• Common Device Name: LIGHT ADJUSTABLE LENS (LAL)
• Manufacturer (Section D): RXSIGHT, INC.; 100 columbia; aliso viejo 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: 13044242
• Report Number: 3012712027-2021-00084
• Device Sequence Number: 13901198
• Product Code: PZK
• UDI-Device Identifier: 00818806020159
• UDI-Public: 01008188060201591120010517221231
• 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): 12/10/2021

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: L02-001491
• 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: 01/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/05/2020
• 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: Male