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

Model Number	60005
Medical Device Problem Code	Optical Problem (3001)
Health Effect - Clinical Code	Visual Disturbances (2140)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Site reported a bilateral patient had both light adjustable lenses explanted due to photopsia.Rxsight's first awareness of the event was (b)(6) 2021.The device history record for the lenses were reviewed.No issues were noted.Right eye: serial number: (b)(4).Lot number: l02-001753.Mfg date: 7/23/2020.Expiration date: 6/30/2023.(b)(4).Left eye: serial number: (b)(4).Lot number: l02-001812.Mfg date: 8/30/2020.Expiration date: 7/31/2023.(b)(4).The lenses have been returned and are currently being evaluated.
Event or Problem Description
Site reported a bilateral patient had both light adjustable lenses explanted due to photopsia.Rxsight's first awareness of the event was (b)(6) 2021.
Additional Manufacturer Narrative
Site reported a bilateral patient had both ligh adjustable lenses explanted due to photopsia.Rxsight's first awareness of the event was 10/18/2021.The explanted lenses were returned for evaluation.Visual inspection and optical testing of the returned lenses confirmed the presence of an ambient zone on the lens, which is indicative of exposure of the lens to ambient uv light prior to lock in.
Event or Problem Description
Site reported a bilateral patient had both ligh adjustable lenses explanted due to photopsia.Rxsight's first awareness of the event was 10/18/2021.

• Brand Name: LIGHT ADJUSTABLE LENS (LAL)
• Common Device Name: LENS ADJUSTABLE LENS
• Manufacturer (Section D): RXSIGHT, INC.; 100 columbia; aliso viejo CA 92656
• Manufacturer (Section G): RXSIGHT, INC.; 100 columbia; aliso viejo CA 92656
• Manufacturer Contact: kelli carrillo ; 100 columbia; aliso viejo, CA 92656
• MDR Report Key: 12800326
• Report Number: 3012712027-2021-00072
• Device Sequence Number: 5718543
• Product Code: PZK
• UDI-Device Identifier: 00818806020173
• UDI-Public: 01008188060201731120072317230630
• 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: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/11/2021

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: 06/30/2023
• Device Model Number: 60005
• Device Catalogue Number: 60005
• Device Lot Number: L02-001753
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/18/2021
• Supplement Date Received by Manufacturer: 10/18/2021
• Initial Report FDA Received Date: 11/11/2021
• Supplement Report FDA Received Date: 12/20/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/23/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male