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

Model Number	60005
Medical Device Problem Code	Optical Decentration (1360)
Health Effect - Clinical Code	Unspecified Eye / Vision Problem (4471)
Date of Event	06/11/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
A site reported to rxsight that a light adjustable lens (lal, sn (b)(6), +21.5) was explanted, and a new lal (sn (b)(6), +22.0d) was implanted as a replacement.Rxsight's first awareness of this event was on 06/11/2024.
Additional Manufacturer Narrative
During the primary cataract surgery on 06/05/2024, the leading haptic of the light adjustable lens (lal, sn (b)(6), +21.5) disinserted from the optic body upon delivery; however, the surgeon did not exchange the lens.An additional procedure was completed on 06/11/2024 to explant the lal, and a new lal (sn (b)(6), +22.0d) was implanted as a replacement.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: 19680836
• Report Number: 3012712027-2024-00110
• Device Sequence Number: 6918224
• Product Code: PZK
• UDI-Device Identifier: 00818806020708
• UDI-Public: 01008188060207081122062417250531
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P160055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/05/2024

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: 05/31/2025
• Device Model Number: 60005
• Device Catalogue Number: 60005
• Device Lot Number: L07-004054
• 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: 06/11/2024
• Initial Report FDA Received Date: 07/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/24/2022
• 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: 68 YR
• Patient Sex: Female