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

Model Number	60005
Medical Device Problem Code	Optical Problem (3001)
Health Effect - Clinical Code	Blurred Vision (2137)
Date of Event	10/11/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
A site reported to rxsight that a light adjustable lens (lal, sn: (b)(6), +18.0d) was implanted in the patient's right eye on (b)(6) 2024 during primary cataract surgery.Two light treatments were completed without complications.On (b)(6) 2024, the patient presented to the clinic with sudden onset blurry vision in the right eye and was diagnosed with macula-off retinal detachment.Retinal detachment repair with endolaser and sf6 was performed on (b)(6) 2024.Following retinal repair surgery, on (b)(6) 2024, the patient was diagnosed with endophthalmitis; a pars plana vitrectomy with culture and silicone oil tamponade were performed on the same day.Bacterial cultures were negative as of on (b)(6) 2024.Superior displacement of the lal with silicone oil on the posterior surface was noted on (b)(6) 2024.On (b)(6) 2024, the silicone oil was removed.On (b)(6) 2024, it was noted that the lal was opacified when observed under slit lamp.The lal (sn: (b)(6) was explanted on (b)(6) 2024 and replaced with an intraocular lens from a different manufacturer.
Additional Manufacturer Narrative
The lal was cut into fragments during explantation and the fragments were returned to rxsight and evaluated; no anomalies or defects were detected in the returned lal.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: 20625996
• Report Number: 3012712027-2024-00199
• Device Sequence Number: 21059295
• Product Code: PZK
• UDI-Device Identifier: 00818806020630
• UDI-Public: 01008188060206301123080417260731
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 11/06/2024

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: L07-005045
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/11/2024
• Initial Report FDA Received Date: 11/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/04/2023
• 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 Age: 65 YR
• Patient Sex: Female