MAUDE Adverse Event Report: AST PRODUCTS, INC. LIOLI IOL DELIVERY SYSTEM

Model Number	LIOLI-24
Medical Device Problem Codes	Off-Label Use (1494); Use of Device Problem (1670)
Health Effect - Clinical Code	Capsular Bag Tear (2639)
Date of Event	06/26/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Reporter stated icl lens was torn on insertion.Doctor noted large tear in icl after implant with the injector.The lens capsule was violated and the surgeon ended up doing a refractive lens exchange.

• Brand Name: LIOLI IOL DELIVERY SYSTEM
• Common Device Name: LIOLI IOL DELIVERY SYSTEM
• Manufacturer (Section D): AST PRODUCTS, INC.; 9 linnell circle; billerica MA 01821
• Manufacturer (Section G): AST PRODUCTS, INC.; 9 linnell circle; billerica MA 01821
• Manufacturer Contact: chanel figueredo ; 9 linnell circle; billerica, MA 01821 ; 9786674500
• MDR Report Key: 17365434
• Report Number: 1000635309-2023-00001
• Device Sequence Number: 17449960
• Product Code: MSS
• UDI-Device Identifier: 10814899027027
• UDI-Public: 10814899027027
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K142056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 07/20/2023

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
• Device Expiration Date: 04/18/2026
• Device Model Number: LIOLI-24
• Device Lot Number: FCK1701
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/29/2023
• Initial Report FDA Received Date: 07/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/18/2023
• 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: Required Intervention
• Patient Sex: Unknown