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

Model Number	60005
Medical Device Problem Code	Optical Distortion (3000)
Health Effect - Clinical Code	Visual Disturbances (2140)
Date of Event	08/30/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Site reported that a patient was having the light adjustable lens explanted from the left eye because the patient was not fully compliant to uv spectacle wear.Rxsight's first awareness of the event was (b)(6) 2021.The device history record for the lens was reviewed.No issues were noted.The lens has been received and is currently undergoing evaluation.
Event or Problem Description
Site reported that a patient was having the light adjustable lens explanted from the left eye because the patient was not fully compliant to uv spectacle wear.Rxsight's first awareness of the event was (b)(6) 2021.
Additional Manufacturer Narrative
Site reported that a patient was having the light adjustable lens explanted from the left eye because the patient was not fully compliant to uv spectacle wear.Rxsight's first awareness of the event was 8/30/2021.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.
Event or Problem Description
Site reported that a patient was having the light adjustable lens explanted from the left eye because the patient was not fully compliant to uv spectacle wear.Rxsight's first awareness of the event was 8/30/2021.

• Brand Name: LIGHT ADJUSTABLE LENS (LAL)
• Common Device Name: LIGHT AJUSTABLE LENS
• Manufacturer (Section D): RXSIGHT, INC.; 100 columbia; aliso viejo CA 92656
• MDR Report Key: 12533861
• Report Number: 3012712027-2021-00056
• Device Sequence Number: 1140763
• Product Code: PZK
• UDI-Device Identifier: 00818806020135
• UDI-Public: 010081880602013517211130
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P160055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/27/2021

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: 11/30/2021
• Device Model Number: 60005
• Device Catalogue Number: 60005
• Device Lot Number: L02-000798
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2021
• Initial Date Received by Manufacturer: 08/30/2021
• Supplement Date Received by Manufacturer: 08/30/2021
• Initial Report FDA Received Date: 09/27/2021
• Supplement Report FDA Received Date: 10/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention