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	04/12/2023
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 treating physician observed the posterior capsular tear in the patient's left eye on (b)(6) 2023.It is the doctor's opinion that the capsular bag was either scratched or compromised during the initial implant surgery which led to the capsular tear later.However, this was not observed at the time of surgery.The patient is seeing well after surgery and the capsule is stable per the doctor's evaluation.Manufacturer reference #: (b)(4).
Event or Problem Description
The site has reported that a light adjustable lens (lal, sn (b)(6), +24.0d) was implanted on (b)(6) 2023.During a post-operative visit, a posterior capsular tear was observed in the patient's eye.Rxsight's first awareness of this event was on (b)(6) 2023.

• 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: 16923748
• Report Number: 3012712027-2023-00037
• Device Sequence Number: 12451616
• Product Code: PZK
• UDI-Device Identifier: 00818806020753
• UDI-Public: 01008188060207531122050917250430
• 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: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/12/2023

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: 04/30/2025
• Device Model Number: 60005
• Device Catalogue Number: 60005
• Device Lot Number: L07-003938
• 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: 04/12/2023
• Initial Report FDA Received Date: 05/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/09/2022
• 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: Disability
• Patient Age: 70 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White