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	01/24/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The site reported that a light adjustable lens had been explanted from the patient's left eye as the desired refractive outcome was not achieved after light adjustment treatments.Another lal was implanted during the exchange on (b)(6) 2022.Rxsight's first awareness of the event occurred on (b)(6) 2022.The device history record was reviewed.No issues were noted.The explanted lens was returned for evaluation.The lens was cut into multiple fragments.The lens was visually inspected.No issues were found.Optical testing could not be performed due to the condition of the lens.
Event or Problem Description
The site reported that a light adjustable lens had been explanted from the patient's left eye as the desired refractive outcome was not achieved after light adjustment treatments.Another lal was implanted during the exchange on (b)(6) 2022.Rxsight's first awareness of the event occurred on (b)(6) 2022.

• Brand Name: LIGHT ADJUSTABLE LENS (LAL)
• Common Device Name: LIGHT ADJUSTABLE LENS (LAL)
• 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: 13733983
• Report Number: 3012712027-2022-00009
• Device Sequence Number: 12004729
• Product Code: PZK
• UDI-Device Identifier: 00818806020142
• UDI-Public: 010081880602014217220630
• 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: 2020
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/04/2022

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: 06/30/2022
• Device Model Number: 60005
• Device Catalogue Number: 60005
• Device Lot Number: L02-001159
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/10/2022
• Initial Report FDA Received Date: 03/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/01/2019
• 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: Male