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

Model Number	60005
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Unspecified Eye / Vision Problem (4471)
Date of Event	02/06/2024
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 patient's light adjustable lens (lal, sn (b)(6), +19.0d) was implanted backwards during primary cataract surgery.An additional surgical procedure was completed to explant the lal and implant a new lal (sn (b)(6), +19.0d) in the proper orientation.Rxsight's first awareness of this event was on 02/06/2024.
Event or Problem Description
A site reported to rxsight that a patient's light adjustable lens (lal, sn (b)(6), +16.5d) was implanted backwards in the right eye (od) during primary cataract surgery.An additional surgical procedure was completed to explant the lal and implant a new lal in the proper orientation.Reference report #3012712027-2024-00061 for the report on the left eye (os).
Additional Manufacturer Narrative
After the initial report was submitted, rxsight received information that clarified the serial number of the lal that was explanted from the patient's right eye (od), which was lal with sn (b)(6).The lal serial number along with the associated medical device information in section d are being corrected in this follow-up report.In addition, the returned lal (sn (b)(6) have been evaluated.No additional findings are avaiable from the evaluation of the returned lens.The investigation conclusions were unchanged.

• 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: 18852291
• Report Number: 3012712027-2024-00032
• Device Sequence Number: 7486218
• Product Code: PZK
• UDI-Device Identifier: 00818806020609
• UDI-Public: 01008188060206091123080717260731
• 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: 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
• Report Date (Section B): 05/10/2024

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: 07/31/2026
• Device Model Number: 60005
• Device Catalogue Number: 60005
• Device Lot Number: L07-005051
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/27/2024
• 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: 04/11/2024
• Initial Report FDA Received Date: 03/06/2024
• Supplement Report FDA Received Date: 05/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/07/2023
• 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: Male
• Patient Race: White