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

Model Number	60005
Medical Device Problem Code	Optical Distortion (3000)
Health Effect - Clinical Code	Visual Disturbances (2140)
Date of Event	06/04/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient implanted with light adjustable lens ((b)(6) 2020) in the right eye admitted to poor compliance with uv spectacles immediately after surgery.Patient developed a loss of visual acuity.The light adjustable lens was explanted (serial number of explanted lens: (b)(4)) and exchanged with another light adjustable lens (serial number of implanted lens: (b)(4)) of the same diopter power on (b)(6) 2020.Patient again did not comply with uv spectacle wear and developed a loss of visual acuity.The lens was explanted on (b)(6) 2020 and exchanged with a 3-piece monofocal iol.Rxsight's first awareness of the explant on (b)(6) 2020 involving serial number (b)(4) was (b)(6) 2020.Rxsight's first awareness of the explant on (b)(6) 2020 involving serial number (b)(4) was 07/23/2020.Device history record for both lenses (serial numbers (b)(4)) were reviewed.No issues were noted.Both lenses are pending return for evaluation.For lens serial number (b)(4): implanted: (b)(6) 2020, explanted (b)(6) 2020, udi: (b)(4), manufactured 8/7/2019, expiration date: 7/31/2022.For lens serial number (b)(4): implanted: (b)(6) 2020, explanted: (b)(6) 2020, udi: (b)(4), manufactured: 8/10/2019, expiration date: 7/31/2022.
Event or Problem Description
Patient implanted with light adjustable lens ((b)(6) 2020) in the right eye admitted to poor compliance with uv spectacles immediately after surgery.Patient developed a loss of visual acuity.The light adjustable lens was explanted (serial number of explanted lens: (b)(4)) and exchanged with another light adjustable lens (serial number of implanted lens: (b)(4)) of the same diopter power on (b)(6) 2020.Patient again did not comply with uv spectacle wear and developed a loss of visual acuity.The lens was explanted on (b)(6) 2020 and exchanged with a 3-piece monofocal iol.Rxsight's first awareness of the explant on (b)(6) 2020 involving serial number (b)(4) was (b)(6) 2020.Rxsight's first awareness of the explant on (b)(6) 2020 involving serial number (b)(4) was 07/23/2020.
Additional Manufacturer Narrative
Patient implanted with light adjustable lens ((b)(6) 2020) in the right eye admitted to poor compliance with uv spectacles immediately after surgery.Patient developed a loss of visual acuity.The light adjustable lens was explanted (serial number of explanted lens: (b)(6)) and exchanged with another light adjustable lens (serial number of implanted lens: (b)(6)) of the same diopter power on (b)(6) 2020.Patient again did not comply with uv spectacle wear and developed a loss of visual acuity.The lens was explanted on (b)(6) 2020 and exchanged with a 3-piece monofocal iol.Rxsight's first awareness of the explant on (b)(6) 2020 involving serial number (b)(6) was (b)(6) 2020.Rxsight's first awareness of the explant on (b)(6) 2020 involving serial number (b)(6) was (b)(6) 2020.Mulitple follow-up attempts were made to have the explanted lenses returned, however, the explanted lenses were not returned for evaluation.
Event or Problem Description
Patient implanted with light adjustable lens ((b)(6) 2020) in the right eye admitted to poor compliance with uv spectacles immediately after surgery.Patient developed a loss of visual acuity.The light adjustable lens was explanted (serial number of explanted lens: (b)(6)) and exchanged with another light adjustable lens (serial number of implanted lens: (b)(6)) of the same diopter power on (b)(6) 2020.Patient again did not comply with uv spectacle wear and developed a loss of visual acuity.The lens was explanted on (b)(6) 2020 and exchanged with a 3-piece monofocal iol.Rxsight's first awareness of the explant on (b)(6) 2020 involving serial number (b)(6) was (b)(6) 2020.Rxsight's first awareness of the explant on (b)(6) 2020 involving serial number (b)(6) was (b)(6) 2020.

• Brand Name: RXSIGHT LIGHT ADJUSTABLE LENS
• Common Device Name: LIGHT ADJUSTABLE LENS (LAL)
• Manufacturer (Section D): RXSIGHT, INC.; 100 columbia; aliso viejo, ca
• MDR Report Key: 10397103
• Report Number: 3012712027-2020-00012
• Device Sequence Number: 17107077
• Product Code: PZK
• UDI-Device Identifier: 00818806020098
• UDI-Public: 010081880602009817220731
• Combination Product (Y/N): N
• 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: 2020
• 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): 08/12/2020

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: 07/31/2022
• Device Model Number: 60005
• Device Catalogue Number: 60005
• Device Lot Number: L02-0001224, L02-0001227
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/08/2020
• Supplement Date Received by Manufacturer: 07/08/2020
• Initial Report FDA Received Date: 08/12/2020
• Supplement Report FDA Received Date: 03/04/2021
• 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