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	07/27/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Site reported bilateral patient had the light adjustable lenses explanted as the desired refractive outcome was not achieved after light adjustment treatments.Both of the lenses were explanted (right eye explanted (b)(6) 2021; left eye explanted (b)(6) 2021).Rxsight's awareness date was 8/10/2021.The device history record for the lenses were reviewed.No issues were noted.Right eye: serial number: (b)(4), lot number: l07-001723, implant date: (b)(6) 2021, mfg date: 7/9/2020, expiration date: 6/30/2023, explant date: (b)(6) 2021, udi: (b)(4).Left eye: serial number: (b)(4).Lot number: l02-001448, implant date: (b)(6) 2021, mfg date: 12/5/2019, expiration date: 11/30/2022, explant date: (b)(6) 2021, udi: (b)(4).The lenses have been received and are currently being evaluated.
Event or Problem Description
Site reported bilateral patient had the light adjustable lenses explanted as the desired refractive outcome was not achieved after light adjustment treatments.Both of the lenses were explanted (right eye explanted (b)(6) 2021; left eye explanted (b)(6) 2021).Rxsight's awareness date was 8/10/2021.
Additional Manufacturer Narrative
Site reported bilateral patient had the light adjustable lenses explanted as the desired refractive outcome was not achieved after light adjustment treatments.Both of the lenses were explanted (right eye explanted on (b)(6) 2021; left eye explanted on (b)(6) 2021).Rxsight's awareness date was 8/10/2021.Both explanted lenses were returned for evaluation.Visual inspection and optical testing of the returned lenses found no issues with the lenses.
Event or Problem Description
Site reported bilateral patient had the light adjustable lenses explanted as the desired refractive outcome was not achieved after light adjustment treatments.Both of the lenses were explanted (right eye explanted on (b)(6) 2021; left eye explanted on (b)(6) 2021).Rxsight's awareness date was 8/10/2021.

• Brand Name: LIGHT ADJUSTABLE LENS (LAL)
• Common Device Name: LIGHT ADJUSTABLE LENS
• Manufacturer (Section D): RXSIGHT, INC.; 100 columbia; aliso viejo CA 92656
• MDR Report Key: 12426051
• Report Number: 3012712027-2021-00049
• Device Sequence Number: 3383045
• Product Code: PZK
• UDI-Device Identifier: 00818806020067
• UDI-Public: 01008188060200671120070917230630
• Combination Product (Y/N): N
• Initial Reporter State: SD
• 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: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 09/03/2021

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: 06/30/2023
• Device Model Number: 60005
• Device Catalogue Number: 60005
• Device Lot Number: L02-001723
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2021
• Initial Date Received by Manufacturer: 08/10/2021
• Supplement Date Received by Manufacturer: 08/10/2021
• Initial Report FDA Received Date: 09/03/2021
• Supplement Report FDA Received Date: 10/06/2021
• 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