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	06/15/2023
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 light adjustable lens (lal sn: (b)(6), +25.0d) was explanted due to a refractive surprise after implant prior to any light treatments.On (b)(6) 2023, 1 week after implant, the patient's uncorrected distance visual acuity (ucdva) was 20/150, manifest refraction (mr) was -3.00 +0.50 x061, and best corrected distance visual acuity (bcdva) was 20/20.The treating physician determined that she may not be able to achieve the planned target due to the large refractive surprise; therefore, she opted to explant the lens and replace it with another lal of a different power.Manufacturer reference #: (b)(4).
Event or Problem Description
The site reported that a light adjustable lens (lal sn: (b)(6), +25.0d) was explanted due to a refractive surprise after implant prior to any light treatments.The lal was explanted and replaced with another lal.Rxsight's date of first awareness was 06/19/2023.

• 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: 17356069
• Report Number: 3012712027-2023-00072
• Device Sequence Number: 20343953
• Product Code: PZK
• UDI-Device Identifier: 00818806020760
• UDI-Public: 01008188060207601121092017240831
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/19/2023

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: 08/31/2024
• Device Model Number: 60005
• Device Catalogue Number: 60005
• Device Lot Number: L07-003449
• 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: 06/19/2023
• Initial Report FDA Received Date: 07/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/20/2021
• 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
• Patient Age: 63 YR
• Patient Sex: Female