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 Impairment (2138)
Date of Event	05/31/2023
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.The site reported that a light adjustable lens (lal sn (b)(6), +13.0d) was explanted and replaced with another lal.Prior to the explant on (b)(6)2023, the patient's uncorrected visual acuity (ucva) was 20/200, manifest refraction (mr) was +1.00 +0.50 x155, and best corrected visual acuity (bcva) was 20/30.For the (b)(6) 2023 visit, there may have been a corneal abrasion caused by a tree branch hitting the patient's eye.The patient has a history of lasik, dry eye syndrome (des), posterior vitreous detachment (pvd), and irregular astigmatism in both eyes (ou).Manufacturer reference #: (b)(4).
Event or Problem Description
The site reported that a bilaterally implanted patient had her left eye (os) light adjustable lens (lal sn (b)(6), +13.0d) explanted due to patient dissatisfaction.The explanted lal was replaced with another lal.Rxsight's first awareness of this event was on 05/31/2023.Reference mdr 3012712027-2023-00058 for the report on the right eye (od).
Additional Manufacturer Narrative
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: 17195409
• Report Number: 3012712027-2023-00057
• Device Sequence Number: 12602624
• Product Code: PZK
• UDI-Device Identifier: 00818806020579
• UDI-Public: 01008188060205791122080217250731
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: P160055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/29/2023

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: 07/31/2025
• Device Model Number: 60005
• Device Catalogue Number: 60005
• Device Lot Number: L07-004144
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/31/2023
• Supplement Date Received by Manufacturer: 05/31/2023
• Initial Report FDA Received Date: 06/23/2023
• Supplement Report FDA Received Date: 11/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/02/2022
• 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: 59 YR
• Patient Sex: Female