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

Model Number	60005
Medical Device Problem Code	Optical Problem (3001)
Health Effect - Clinical Code	Visual Impairment (2138)
Date of Event	09/01/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Light adjustable lens was explanted on (b)(6) 2020 from patient's right eye as desired refractive outcome was not achieved after light adjustment treatments.Device history record for the lens was reviewed.No issues were noted.The explanted lens is in process of being returned for evaluation.
Event or Problem Description
Light adjustable lens was explanted on (b)(6) 2020 from patient's right eye as desired refractive outcome was not achieved after light adjustment treatments.
Event or Problem Description
Light adjustable lens was explanted on (b)(6) 2020 from patient's right eye as desired refractive outcome was not achieved after light adjustment treatments.
Additional Manufacturer Narrative
Light adjustable lens was explanted on (b)(6) 2020 from patient's right eye as desired refractive outcome was not achieved after light adjustment treatments.Three lens fragments that comprised the lens was returned.Visual inspection found no issues with the lens fragments.Optical quality of the lens was also assessed and no issues were noted.

• Brand Name: RXSIGHT LIGHT ADJUSTABLE LENS (RXLAL)
• Common Device Name: LIGHT ADJUSTABLE LENS (LAL)
• Manufacturer (Section D): RXSIGHT, INC.; 100 columbia; aliso viejo CA 92656
• MDR Report Key: 10607400
• Report Number: 3012712027-2020-00021
• Device Sequence Number: 11712761
• Product Code: PZK
• UDI-Device Identifier: 00818806020111
• UDI-Public: 010081880602011117220930
• Combination Product (Y/N): N
• Initial Reporter State: ID
• 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: 2020
• 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): 09/30/2020

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: 09/30/2022
• Device Model Number: 60005
• Device Catalogue Number: 60005
• Device Lot Number: L02-001374
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 09/01/2020
• Supplement Date Received by Manufacturer: 12/15/2020
• Initial Report FDA Received Date: 09/30/2020
• Supplement Report FDA Received Date: 02/08/2021
• 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
• Patient Age: 78 YR