MAUDE Adverse Event Report: RXSIGHT, INC. LIGHT ADJUSTABLE LENS (LAL); LIGHT ADJUSTABLE LENS (LAL0

Model Number	60005
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	Capsular Bag Tear (2639)
Date of Event	04/13/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Physician reported during delivery of the lal, the surgeon felt the lens exited the cartridge quickly, causing a tear in the bag at the equator.The surgeon was able to complete the surgery without additional issue.The device history record for the lens was reviewed.No issues were noted.The lens remains implanted in the patient's eye.
Event or Problem Description
Physician reported during delivery of the lal, the surgeon felt the lens exited the cartridge quickly, causing a tear in the bag at the equator.The surgeon was able to complete the surgery without additional issue.

• Brand Name: LIGHT ADJUSTABLE LENS (LAL)
• Common Device Name: LIGHT ADJUSTABLE LENS (LAL0
• Manufacturer (Section D): RXSIGHT, INC.; 100 columbia; aliso viejo CA 92656
• MDR Report Key: 11739588
• Report Number: 3012712027-2021-00019
• Device Sequence Number: 4167671
• Product Code: PZK
• UDI-Device Identifier: 00818806020173
• UDI-Public: 01008188060201731120091617230831
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: P160055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/28/2021

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: 08/31/2023
• Device Model Number: 60005
• Device Catalogue Number: 60005
• Device Lot Number: L02-001833
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/13/2021
• Initial Report FDA Received Date: 04/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other