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

Model Number	60005
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Visual Impairment (2138)
Date of Event	03/01/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Site reported that the patient was dissatisfied with the outcome.The doctor aimed for monovision while the patient wanted both eyes for distance vision.The lens was explanted on (b)(6) 2021.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
Site reported that the patient was dissatisfied with vision.The doctor aimed for monovision, however, the patient wanted distance vision for both eyes.The lens was explanted on (b)(6) 2021.
Additional Manufacturer Narrative
Site reported that the patient was dissatisfied with vision.The doctor aimed for monovision, however, the patient wanted distance vision for both eyes.The lens was explanted on (b)(6) 2021.The explanted lens was not returned for evaluation despite follow-ups.
Event or Problem Description
Site reported that the patient was dissatisfied with vision.The doctor aimed for monovision, however, the patient wanted distance vision for both eyes.The lens was explanted on (b)(6) 2021.

• Brand Name: LIGHT ADJUSTABLE LENS (LAL)
• Common Device Name: LIGHT ADJUSTABLE LENS (LAL)
• Manufacturer (Section D): RXSIGHT, INC.; 100 columbia; aliso viejo CA 92656
• MDR Report Key: 11569323
• Report Number: 3012712027-2021-00014
• Device Sequence Number: 4455499
• Product Code: PZK
• UDI-Device Identifier: 00818806020234
• UDI-Public: 0100818806020234111911072210312120013980417
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/25/2021

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: 10/31/2022
• Device Model Number: 60005
• Device Catalogue Number: 60005
• Device Lot Number: L02-001398
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/01/2021
• Supplement Date Received by Manufacturer: 03/01/2021
• Initial Report FDA Received Date: 03/25/2021
• Supplement Report FDA Received Date: 07/20/2021
• 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: Other