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

Model Number	60005
Medical Device Problem Code	Optical Distortion (3000)
Health Effect - Clinical Code	Visual Disturbances (2140)
Date of Event	09/16/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Site reported bilateral patient was not fully compliant to uv spectacle wear.Both of the lenses were explanted (right eye explanted (b)(6) 2021; left eye explanted (b)(6) 2021).Rxsight's awareness date was 10/8/2021.The device history record for the lenses were reviewed.No issues were noted.Right eye: serial number: (b)(4), lot number: l02-001817, mfg date: 9/1/2020, expiration date: 8/31/2023, explant date: (b)(6) 2021, udi: (b)(4).Left eye: serial number: (b)(4), lot number: l02-003064, mfg date: 3/19/2021, expiration date: 2/29/2024, explant date: (b)(6) 2021, udi: (b)(4).The lenses have not yet been received for evaluation.
Event or Problem Description
Site reported bilateral patient was not fully compliant to uv spectacle wear.Both of the lenses were explanted (right eye explanted (b)(6) 2021; left eye explanted (b)(6) 2021).Rxsight's awareness date was 10/8/2021.
Additional Manufacturer Narrative
Site reported bilateral patient was not fully compliant to uv spectacle wear.Both of the lenses were explanted (right eye explanted (b)(6) 2021; left eye explanted (b)(6) 2021).Rxsight's awareness date was 10/8/2021.The lenses were not saved after explant.The site discarded the lenses.
Event or Problem Description
Site reported bilateral patient was not fully compliant to uv spectacle wear.Both of the lenses were explanted (right eye explanted (b)(6) 2021; left eye explanted (b)(6) 2021).Rxsight's awareness date was 10/8/2021.

• Brand Name: LIGHT ADJUSTABLE LENS (LAL)
• Common Device Name: LIGHT ADJUSTABLE LENS
• 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: 12752244
• Report Number: 3012712027-2021-00068
• Device Sequence Number: 18387421
• Product Code: PZK
• UDI-Device Identifier: 00818806020166
• UDI-Public: 01008188060201661120090117230831
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 11/02/2021

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: 08/31/2023
• Device Model Number: 60005
• Device Catalogue Number: 60005
• Device Lot Number: L02-001817
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/08/2021
• Supplement Date Received by Manufacturer: 10/08/2021
• Initial Report FDA Received Date: 11/04/2021
• Supplement Report FDA Received Date: 12/28/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2020
• 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: Unknown