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

Model Number LIOLI-24

Device Problems Off-Label Use (1494); Use of Device Problem (1670)

Patient Problem Capsular Bag Tear (2639)

Event Date 06/26/2023

Event Type  Injury  

Event 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
• Type of Device: 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
• MDR Text Key: 319451373
• Report Number: 1000635309-2023-00001
• Device Sequence Number: 1
• Product Code: MSS
• UDI-Device Identifier: 10814899027027
• UDI-Public: 10814899027027
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 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 Model Number: LIOLI-24
• Device Lot Number: FCK1701
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/29/2023
• Initial Date FDA Received: 07/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/18/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention