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

Model Number	60005
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Visual Impairment (2138)
Date of Event	02/22/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The site reported that a light adjustable lens (lal, sn (b)(4), +14.0d) was explanted due to being implanted backwards.Rxsight's first awareness of this event was on 02/23/2023.
Additional Manufacturer Narrative
After the first lock-in light treatment visit, it was discovered that the lal (sn (b)(4) was implanted backwards.Initially, the treating physician and the patient decided to leave the lens in the eye as is since the patient was happy with their vision.No additional light treatments were performed.Later, the patient decided they wanted the lal removed and replaced with a new lal.The explant surgery was completed on (b)(6) 2023.The explanted lal was not returned to rxsight by the site.Further evaluation of the lens is not possible.The device history record for the manufacturing lot was reviewed and there were no discrepancies or unusual findings.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: 16616074
• Report Number: 3012712027-2023-00021
• Device Sequence Number: 17357311
• Product Code: PZK
• UDI-Device Identifier: 00818806020586
• UDI-Public: 01008188060205861122041517250331
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P160055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/24/2023

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: 03/31/2025
• Device Model Number: 60005
• Device Catalogue Number: 60005
• Device Lot Number: L07-003877
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/23/2023
• Initial Report FDA Received Date: 03/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/15/2022
• 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: 76 YR
• Patient Sex: Male