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	02/02/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Bilateral patient reported a decrease in vision in both eyes and non-compliance with uv spectacle wear.The doctor suspects premature photopolymerization of both lenses.One lens was exchanged on (b)(6) 2021 and the second lens exchange occurred on (b)(6) 2021.Rxsight's first awareness of the lens exchange was (b)(6) 2021.Device history record for the lenses were reviewed.No issues were noted.Right eye: serial number: (b)(4), implant date: (b)(6) 2020, expiration date: 10/31/2022 udi: (b)(4).Left eye: serial number: (b)(4), implant date: (b)(6) 2020, expiration date: 9/30/2022 udi: (b)(4).The explanted lenses have been returned and are currently being evaluated.
Event or Problem Description
Bilateral patient reported a decrease in vision in both eyes and non-compliance with uv spectacle wear.The doctor suspects premature photopolymerization of both lenses.One lens was exchanged on (b)(6) 2021 and the second lens exchange occurred on (b)(6) 2021.Rxsight's first awareness of the lens exchange was (b)(6) 2021.
Event or Problem Description
Bilateral patient reported a decrease in vision in both eyes and non-compliance with uv spectacle wear.The doctor suspects premature photopolymerization of both lenses.One lens was exchanged on (b)(6) 2021 and the second lens exchange occurred on (b)(6) 2021.
Additional Manufacturer Narrative
Bilateral patient reported a decrease in vision in both eyes and non-compliance with uv spectacle wear.The doctor suspects premature photopolymerization of both lenses.One lens was exchanged on (b)(6) 2021 and the second lens exchange occurred on (b)(6) 2021.The explanted lenses were returned for evaluation.Inspection and optical testing of the returned lenses confirmed the presence of a zone in the center of the lenses which is indicative of premature photopolymerization of the lenses.

• 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: 11440565
• Report Number: 3012712027-2021-00008
• Device Sequence Number: 11647585
• Product Code: PZK
• UDI-Device Identifier: 00818806020234
• UDI-Public: 010081880602023417220930
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): 03/08/2021

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: L02-001335
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2021
• Initial Date Received by Manufacturer: 02/08/2021
• Supplement Date Received by Manufacturer: 02/08/2021
• Initial Report FDA Received Date: 03/08/2021
• Supplement Report FDA Received Date: 04/07/2021
• 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