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	Visual Disturbances (2140)
Date of Event	02/13/2024
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.Manufacturer reference #: (b)(4).
Event or Problem Description
A site reported to rxsight that a bilaterally implanted patient's light adjustable lens+ (lal+, sn (b)(6), +21.0d) was explanted from the left eye due to visual disturbances and the patient's complaint of pressure and pain.An intra-ocular lens (+21.5d) from a different manufacturer was implanted as a replacement.Rxsight's first awareness of this event was on 02/13/2024.Reference report #3012712027-2024-00037 for the report on the right eye (od).
Additional Manufacturer Narrative
This mdr is submitted to provide a correction to section b5 of the initial mdr.
Event or Problem Description
Reference report #(b)(4) for the report on the right eye (od).
Additional Manufacturer Narrative
The lal was cut into two pieces during the explant procedure.Only a simple visual inspection can be performed; no additional test was able to be performed on the lal fragments.Section h6 codes were updated.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: 18887245
• Report Number: 3012712027-2024-00036
• Device Sequence Number: 3089519
• Product Code: PZK
• UDI-Device Identifier: 00818806021606
• UDI-Public: 01008188060216061123021017260131
• 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: 2024
• 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,Followup
• Report Date (Section B): 11/12/2024

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: 01/31/2026
• Device Model Number: 60005
• Device Catalogue Number: 60005
• Device Lot Number: L08-004567
• 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: 03/12/2024
• Supplement Date Received by Manufacturer: 03/12/2024; Not provided
• Initial Report FDA Received Date: 03/12/2024
• Supplement Report FDA Received Date: 03/12/2024; 11/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/10/2023
• 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 Sex: Female