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

Model Number	60007
Medical Device Problem Code	Optical Decentration (1360)
Health Effect - Clinical Code	Capsular Bag Tear (2639)
Date of Event	09/26/2025
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 that a capsular tear occurred during implantation of a patient's light adjustable lens+ (lal+, sn: (b)(6), +24.0d), causing the lens to fall posteriorly to the capsular bag.The surgeon was unable to remove the lal+ during primary surgery.Additionally, the trailing haptic was disinserted from its junction during the lens extraction attempt.An anterior vitrectomy was performed.The patient was subsequently referred to a retinal specialist, who performed the lal explant.A new lal was implanted in the sulcus.
Additional Manufacturer Narrative
This supplemental is being submitted to provide additional information to the following sections: b3, d6b, h11.The patient was subsequently referred to a retinal specialist, who performed the lal+ explant on (b)(6) 2025.A new lal was implanted in the sulcus.

• 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: 23383290
• Report Number: 3012712027-2025-00371
• Device Sequence Number: 4863511
• Product Code: PZK
• UDI-Device Identifier: 00818806021668
• UDI-Public: 01008188060216681125041517280331
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P160055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• 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): 12/03/2025

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 Model Number: 60007
• Device Catalogue Number: 60007
• Device Lot Number: L08-008476
• 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: 09/25/2025
• Supplement Date Received by Manufacturer: 11/06/2025
• Initial Report FDA Received Date: 10/24/2025
• Supplement Report FDA Received Date: 12/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/15/2025
• 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: Disability; Required Intervention
• Patient Age: 71 YR
• Patient Sex: Female