MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON ACRYSOF SINGLEPIECE IOL; INTRAOCULAR LENS

Model Number SN60AT

Device Problem Fracture (1260)

Patient Problem Insufficient Information (4580)

Event Date 02/17/2022

Event Type  malfunction  

Event Description

A non healthcare professional reported during an intraocular lens implant procedure, surgeon noticed a fracture in the lens.The lens was then cut out and replaced with backup lens.Additional information has been requested.

Manufacturer Narrative

The explanted lens was returned positioned incorrectly in the lens case.Viscoelastic was dried on the lens.Viscoelastic and blood was dried on the lens.The optic was broken and cut into three portions.Both haptics are fully intact.Information provided in the file indicated the use of a non-qualified company iii d cartridge with a company iii handpiece and a non-qualified viscoelastic.The lens is qualified for use in the company b and c cartridges with company viscoelastic.There have been no other complaints reported in the lot number.Broken optic damage was observed.This damage was most likely interpreted as the reported complaint.The root cause for the reported complaint may be¿related¿a failure to follow the ifu.A non-qualified cartridge model and viscoelastic combination was indicated.The ifu instructs that company qualified delivery system and viscoelastic combination should be used.The use of an unqualified combination may cause damage to the lens and potential complications during the implantation process.Company recommends using the qualified company iol delivery system or any other company qualified combination.Information was provided that the 21.0d lens was removed and replaced with another 21.0d lens model.No further information has been provided.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF SINGLEPIECE IOL
• Type of Device: INTRAOCULAR LENS
• Manufacturer (Section D): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• Manufacturer (Section G): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 13853495
• MDR Text Key: 287665125
• Report Number: 1119421-2022-00527
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 00380650130327
• UDI-Public: 00380650130327
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P930014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SN60AT
• Device Catalogue Number: SN60AT.210
• Device Lot Number: 15224946
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2022
• Date Manufacturer Received: 02/22/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D; MONARCH III IOL DELIVERY SYSTEM, INJECTOR; PROVISC OPHTHALMIC VISCOSURGICAL DEVICE