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)
Type of Reportable Event	Serious Injury
Event or Problem Description
Site reported bilateral patient had both light adjustable lenses explanted as the desired refractive outcome was not achieved after light adjustment treatments.Rxsight's awareness date was 10/14/2021.
Additional Manufacturer Narrative
Site reported bilateral patient had both light adjustable lenses explanted as the desired refractive outcome was not achieved after light adjustment treatments.Rxsight's awareness date was 10/14/2021.The device history record for the lenses were reviewed.No issues were noted.Serial number: (b)(4), lot number: l02-001446, mfg date: 12/4/2019, expiration date: 11/30/2022, udi: (b)(4).Serial number: (b)(4), lot number: l02-001525, mfg date: 1/4/2020, expiration date: 12/31/2022, udi: (b)(4).The explanted lenses were returned and are currently being evaluated.
Additional Manufacturer Narrative
Site reported bilateral patient had both light adjustable lenses explanted as the desired refractive outcome was not achieved after light adjustment treatments.Rxsight's awareness date was 10/14/2021.The explanted lenses were returned for evaluation.The lenses were cut into multiple fragments.Visual and optical testing found no issues with the lenses.
Event or Problem Description
Site reported bilateral patient had both light adjustable lenses explanted as the desired refractive outcome was not achieved after light adjustment treatments.Rxsight's awareness date was 10/14/2021.

• 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: 12778982
• Report Number: 3012712027-2021-00070
• Device Sequence Number: 5942163
• Product Code: PZK
• UDI-Device Identifier: 00818806020210
• UDI-Public: 01008188060202101119120417221130
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: P160055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/08/2021

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: 11/30/2022
• Device Model Number: 60005
• Device Catalogue Number: 60005
• Device Lot Number: L02-001446
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/14/2021
• Supplement Date Received by Manufacturer: 10/14/2021
• Initial Report FDA Received Date: 11/09/2021
• Supplement Report FDA Received Date: 12/20/2021
• Was Device Evaluated by Manufacturer? (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