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

Model Number	60005
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Visual Impairment (2138)
Date of Event	06/16/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
A site reported to rxsight that a patient's light adjustable lens (lal, sn (b)(6), +18.0d) was explanted and a new lal (sn (b)(6), +4.0d) was implanted as a replacement.Rxsight's first awareness of this event was on 02/20/2024.
Additional Manufacturer Narrative
The patient's lal (sn (b)(6), +18.0d) was explanted due to a refractive surprise after implant and prior to any light treatments.On (b)(6) 2023, the manifest refraction was -15.25 + 0.75 x 165, and the best corrected visual acuity was 20/60.The lal was explanted on (b)(6) 2023 and was replaced by another lal (sn (b)(6), +4.0d).Based on the available information, the initial iol power choice was not a good fit for this eye.Manufacturer reference #: (b)(4).
Additional Manufacturer Narrative
The explanted lal was returned and evaluated by rxsight.Code 10 is being added to section h6, type of investigation (b).There were no additional findings related to the reported issue.The investigation conclusion remain unchanged.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: 18954444
• Report Number: 3012712027-2024-00044
• Device Sequence Number: 4580154
• Product Code: PZK
• UDI-Device Identifier: 00818806020630
• UDI-Public: 01008188060206301121081417240731
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/27/2024

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: 07/31/2024
• Device Model Number: 60005
• Device Catalogue Number: 60005
• Device Lot Number: L07-003372
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/29/2024
• 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: 06/06/2024
• Initial Report FDA Received Date: 03/21/2024
• Supplement Report FDA Received Date: 06/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/14/2021
• 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; Required Intervention
• Patient Age: 48 YR
• Patient Sex: Male