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	12/05/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
A site reported to rxsight that during the delivery of a light adjustable lens (lal, sn(b)(6), +18.5d), the capsular bag was punctured.The partially deployed lal was withdrawn.Another lal of the same power was implanted in the capsular bag with no complications.Rxsight's first awareness of the event was on 12/06/2023.
Additional Manufacturer Narrative
The device history record for the manufacturing lot was reviewed and there were no discrepancies or unusual findings.Manufacturer reference #: (b)(4).
Additional Manufacturer Narrative
The site reported to rxsight that the shape and size of the posterior capsule puncture was consistent with the dimensions of the lead haptic.The site also reported that no tearing of the posterior capsule was noted during the initial haptic puncture and subsequent withdrawal of the partially inserted or deployed lens.The replacement lal was placed inside the capsule bag.The lal was still folded within the cartridge nozzle when it was returned to rxsight for evaluation.It was noted that the leading haptic was outside of the cartridge.No abnormalities were found for the lal.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: 18375454
• Report Number: 3012712027-2023-00121
• Device Sequence Number: 7710423
• Product Code: PZK
• UDI-Device Identifier: 00818806020647
• UDI-Public: 01008188060206471123050717260430
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/19/2024

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: 04/30/2026
• Device Model Number: 60005
• Device Catalogue Number: 60005
• Device Lot Number: L07-004800
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/06/2023
• Supplement Date Received by Manufacturer: 03/14/2024
• Initial Report FDA Received Date: 12/21/2023
• Supplement Report FDA Received Date: 03/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/07/2023
• 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