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

Model Number	20012020409
Medical Device Problem Code	Optical Problem (3001)
Health Effect - Clinical Code	Visual Impairment (2138)
Date of Event	11/09/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The site reported that a light adjustable lens (lal) was explanted due to suspected ambient zone formation.Rxsight's first awareness of this event was on 11/04/2022.
Additional Manufacturer Narrative
The device history record for the manufacturing lot was reviewed and there were no discrepancies or unusual findings.The patient's left eye (os) was implanted on (b)(6) 2020 and all required light treatments were completed on (b)(6) 2020.At a follow-up visit on (b)(6) 2021, best corrected distance visual acuity (bcdva) was 20/70.A yag capsulotomy was performed on (b)(6) 2022.At a subsequent visit on (b)(6) 2022, bcdva was 20/60.The patient returned to the clinic on (b)(6)2022, bcdva was 20/40-.The examining physician observed a small defect on the lens centrally with the ophthalmoscope and suspects a possible zone formation.The lal (sn: (b)(4) was explanted on (b)(6) 2022.The explanted lens is in the process of being returned to rxsight for evaluation.Manufacturer reference #: 1562.

• 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: 15811758
• Report Number: 3012712027-2022-00052
• Device Sequence Number: 5501453
• Product Code: PZK
• UDI-Device Identifier: 00818806020234
• UDI-Public: 010081880602023417220630
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: P160055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/16/2022

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: 06/30/2022
• Device Model Number: 20012020409
• Device Catalogue Number: 60005
• Device Lot Number: L02-001202
• 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: 11/04/2022
• Initial Report FDA Received Date: 11/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/25/2019
• 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: 57 YR
• Patient Sex: Female