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

Model Number	60005
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Halo (2227)
Date of Event	07/18/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device history record for the manufacturing lot was reviewed and there were no discrepancies or unusual findings.The site reported that the patient's near visual acuity was okay but sees halos or double in the distance, especially at night.Central vision was okay but the further out from central, visual acuity becomes more blurry.The patient started complaining of halos after the first light treatment.After two light treatments, the patient still has the same issues.The patient did not complete any additional adjustment or lock-in light treatments.The treating physician decided that it would be best to explant and replace with a new lal (sn (b)(6), +24.0d).Manufacturer reference #: (b)(4).
Event or Problem Description
The site reported that a light adjustable lens (lal, sn (b)(6), +24.0d) was explanted due to the patient experiencing halos.The original lal was explanted and replaced with a new lal (sn (b)(6), +24.0d).Rxsight's first awareness of this event was on (b)(6) 2023.
Additional Manufacturer Narrative
Manufacturer reference #: (b)(4).

• Brand Name: LIGHT ADJUSTABLE LENS (LAL)
• Common Device Name: LIGHT ADJUSTABLE LENS (LAL)
• Manufacturer (Section D): RXSIGHT, INC.; 100 columbia; aliso viejo CA 92656
• Manufacturer (Section G): RXSIGHT, INC.; 100 columbia; aliso viejo CA 92656
• Manufacturer Contact: jim zhang ; 100 columbia; aliso viejo, CA 92656 ; 9492736163
• MDR Report Key: 17569256
• Report Number: 3012712027-2023-00075
• Device Sequence Number: 12826661
• Product Code: PZK
• UDI-Device Identifier: 00818806020753
• UDI-Public: 01008188060207531122090617250831
• 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: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/01/2023

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: 08/31/2025
• Device Model Number: 60005
• Device Catalogue Number: 60005
• Device Lot Number: L07-004236
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 07/18/2023
• Initial Report FDA Received Date: 08/17/2023
• Supplement Report FDA Received Date: 12/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/06/2022
• 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: Required Intervention
• Patient Age: 66 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic