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)
Type of Reportable Event	Serious Injury
Event or Problem Description
The site reported that during the implant surgery for a light adjustable lens (lal, sn (b)(6), +23.5d), a capsular bag tear occurred.The surgeon placed the lal in the sulcus.Rxsight's first awareness of this event was on 06/27/2023.
Additional Manufacturer Narrative
The device history record for the manufacturing lot was reviewed and there were no discrepancies or unusual findings.The site reported during the primary implant surgery, a capsular bag tear occurred, and the light adjustable lens (lal) was placed in the sulcus with optic capture.During follow-up visit, the vitreous was observed in the haptic junction and anterior chamber, but not extending to the wound.The patient was referred to a retinal specialist for clean-up and anterior vitrectomy.After the retinal visit, the patient returned to the implanting surgeon, and at that time, it was observed that the patient had a significantly elevated intraocular pressure (iop).An anterior chamber paracentesis (ac tap) was performed to relieve the pressure.Subsequently, the patient developed endophthalmitis.The patient recovered after the treatment, and their best-corrected visual acuity (bcva) was 20/25+.This event is being documented here for completeness.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: 17410606
• Report Number: 3012712027-2023-00073
• Device Sequence Number: 18386474
• Product Code: PZK
• UDI-Device Identifier: 00818806020746
• UDI-Public: 01008188060207461121103017240930
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: P160055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 07/27/2023

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: 09/30/2024
• Device Model Number: 60005
• Device Catalogue Number: 60005
• Device Lot Number: L07-003521
• 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: Not provided
• Initial Report FDA Received Date: 07/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/30/2021
• 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: Disability
• Patient Sex: Unknown