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	Capsular Bag Tear (2639)
Date of Event	11/02/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The site reported that a light adjustable lens (lal) was explanted due to a capsular bag tear during the implant surgery.The implant surgery and the capsular bag tear occurred on (b)(6) 2022.The lens went into the vitreous and was later explanted by a retinal specialist on (b)(6) 2022.Rxsight's first awareness of the event was on (b)(6) 2022.
Additional Manufacturer Narrative
The device history record for the manufacturing lot was reviewed and there were no discrepancies or unusual findings.The light adjustable lens (lal) was implanted on (b)(6) 2022.During the surgery, the capsular bag was torn because the patient moved, which led to the iol going into the vitreous and a subsequent choroidal hemorrhage.The patient was referred to a retinal specialist.Due to the presence of choroidal hemorrhage, the explant could not have been performed until it was resolved.The retinal specialist was able to explant the lal on (b)(6) 2022 and replace it with a different iol.Manufacturer reference #: (b)(6).

• 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: 15983751
• Report Number: 3012712027-2022-00067
• Device Sequence Number: 5724596
• Product Code: PZK
• UDI-Device Identifier: 00818806020821
• UDI-Public: 01008188060208211121071717240630
• 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: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician Assistant
• Type of Report: Initial
• Report Date (Section B): 12/14/2022

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: 06/30/2024
• Device Model Number: 60005
• Device Catalogue Number: 60005
• Device Lot Number: L07-003323
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/29/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/14/2022
• Initial Report FDA Received Date: 12/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/17/2021
• 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: Male
• Patient Race: White