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

Model Number	60005
Medical Device Problem Code	Optical Distortion (3000)
Health Effect - Clinical Code	Visual Disturbances (2140)
Date of Event	02/18/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient reported experiencing dysphotopsia and anisometropia.The light adjustable lens was explanted from the patient's right eye on (b)(6) 2021.Device history record for the lens was reviewed.No issues were noted.The lens is in process of being returned for evaluation.
Event or Problem Description
Patient reported experiencing dysphotopsia and anisometropia.The light adjustable lens was explanted from the patient's right eye on (b)(6) 2021.
Additional Manufacturer Narrative
Patient reported experiencing dysphotopsia and anisometropia.The light adjustable lens was explanted from the patient's right eye on (b)(6) 2021.It is unknown when the light adjustable lens in the patient's left eye was explanted, although the explanted lens was received on (b)(6) 2021.Device history record for the lenses were reviewed.No issues were noted.Right eye: serial number: (b)(6); date of implant: (b)(6) 2020; date of explant: (b)(6) 2021; date of manufacture: 10/31/2019; date explanted lens returned to manufacturer: (b)(6) 2021; expiration date: 9/30/2022; udi: (b)(4).Left eye: serial number: (b)(6); date of implant: (b)(6) 2020; date of explant: unknown; date of manufacture: 11/5/2019; date explanted lens returned to manufacturer: (b)(6) 2021; expiration date: 10/31/2022; udi: (b)(4).Both lenses were returned for evaluation.Visual inspection and optical testing of the lenses identified the presence of a zone on both lenses.The presence of the zones are indicative of premature photopolymerization of the lenses.
Event or Problem Description
Patient reported experiencing dysphotopsia and anisometropia.The light adjustable lens was explanted from the patient's right eye on (b)(6) 2021.It is unknown when the light adjustable lens in the patient's left eye was explanted, although the explanted lens was received 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: 11517788
• Report Number: 3012712027-2021-00011
• Device Sequence Number: 3932574
• Product Code: PZK
• UDI-Device Identifier: 00818806020180
• UDI-Public: 01008188060201801119103117220930
• 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: 2021
• 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): 03/18/2021

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: No Information
• Device Expiration Date: 09/30/2022
• Device Model Number: 60005
• Device Catalogue Number: 60005
• Device Lot Number: L02-001385
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2021
• Initial Date Received by Manufacturer: 02/18/2021
• Supplement Date Received by Manufacturer: 02/18/2021
• Initial Report FDA Received Date: 03/18/2021
• Supplement Report FDA Received Date: 06/04/2021
• 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