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	03/24/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient reported a decrease in vision in the left eye following an evening outdoors without uv spectacle wear.Patient had not yet been locked in.Doctor suspects premature photopolymerization of the lens.The lens was removed on (b)(6) 2021 and replaced with another light adjustable lens.Device history record for the lens was reviewed.No issues were noted.The explanted lens has been returned and is being evaluated.
Event or Problem Description
Patient reported a decrease in vision in the left eye following an evening outdoors without uv spectacle wear.Patient had not yet been locked in.Doctor suspects premature photopolymerization of the lens.The lens was removed on (b)(6) 2021 and replaced with another light adjustable lens.
Event or Problem Description
Patient reported a decrease in vision in the left eye following an evening outdoors without uv spectacle wear.Patient had not yet been locked in.Doctor suspects premature photopolymerization of the lens.The lens was removed on (b)(6) 2021 and replaced with another light adjustable lens.
Additional Manufacturer Narrative
Patient reported a decrease in vision in the left eye following an evening outdoors without uv spectacle wear.Patient had not yet been locked in.Doctor suspects premature photopolymerization of the lens.The lens was removed on (b)(6) 2021 and replaced with another light adjustable lens.Visual inspection of the returned lens found the lens had been cut into multiple fragments.Visual inspection and optical testing could not confirm the presence of a zone on the lens due to the extensive damage to the lens.

• 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: 11703872
• Report Number: 3012712027-2021-00018
• Device Sequence Number: 3721728
• Product Code: PZK
• UDI-Device Identifier: 00818806020210
• UDI-Public: 01008188060202101120080217230731
• 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: 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,Followup
• Report Date (Section B): 04/21/2021

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: 07/31/2023
• Device Model Number: 60005
• Device Catalogue Number: 60005
• Device Lot Number: L02-001765
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/26/2021
• Initial Date Received by Manufacturer: 03/24/2021
• Supplement Date Received by Manufacturer: 03/24/2021
• Initial Report FDA Received Date: 04/21/2021
• Supplement Report FDA Received Date: 05/04/2021
• 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