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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/21/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The site reported that a bilateral patient was initially planned for monovision (distance in right eye and near vision for left eye), but after implantation and light adjustment treatments, the patient changed her mind and wanted distance vision for both eyes.The light adjustable lens in the left eye was explanted and replaced with another light adjustable lens in order to achieve distance vision in both eyes.Device history record for the lens was reviewed.No issues were noted.The explanted lens was not saved for return.No product is expected back.
Event or Problem Description
The site reported that a bilateral patient was initially planned for monovision (distance in right eye and near vision for left eye), but after implantation and light adjustment treatments, the patient changed her mind and wanted distance vision for both eyes.The light adjustable lens in the left eye was explanted and replaced with another light adjustable lens in order to achieve distance vision in both eyes.

• 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: 12194073
• Report Number: 3012712027-2021-00033
• Device Sequence Number: 3397849
• 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
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 07/19/2021

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?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/21/2021
• Initial Report FDA Received Date: 07/19/2021
• 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