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

Model Number SN60WF

Device Problem Failure to Advance (2524)

Patient Problem Insufficient Information (4580)

Event Date 05/16/2022

Event Type  malfunction  

Event Description

A non-healthcare professional reported during an intraocular lens (iol) implant procedure, lens got struck in injector.

Manufacturer Narrative

Complaint history and product history records were reviewed and documentation indicated the product met release criteria.There have been no other complaints reported in the lot number.The lens was returned in a company cartridge.Inadequate viscoelastic was observed in the cartridge.The lens was advanced to the nozzle entry area.The lens was incorrectly pressed up against roof of the cartridge.The tip of the cartridge had a large aneurysm on the right side and heavy stress.The cartridge had evidence of placement into a handpiece.The cartridge was cleaned for further evaluation.The lens was removed with cleaning.Top coat dye stain testing was conducted with acceptable results.The root cause for the reported "lens stuck" appears to be related to a failure to follow the instructions for use (ifu).The lens was incorrectly pressed up against roof of the cartridge.The lens position pressed up instead of down and the extensive cartridge tip damage would indicate a plunger underride occurred.Inadequate viscoelastic was also observed in the cartridge.The ifu instructs: the lens should be inserted until the optic is a little more than half-way inside the cartridge.Use the holding forceps to gently push down on the lens, verifying that the lens is on the bottom surface of the cartridge.Using holding forceps, take the trailing haptic, and gently fold the haptic onto the anterior side of the optic.Slowly grip or push the optic edge to position the lens as far into the cartridge as the forceps will permit, while ensuring the lens remains on the bottom surface of the cartridge and the trailing haptic remains on the optic.Failure to follow these steps may cause the lens to advance incorrectly causing delivery issues and/or damage.The ifu also instructs to completely fill the cartridge with viscoelastic immediately prior to loading and delivery of the lens.Do not attempt to load the lens without adequate ovd in the device.Not adequately filling the device with viscoelastic will result in inadequate coverage of lens and the lens fold path with viscoelastic, which may result in damage.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF IQ NATURAL 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: 16677199
• MDR Text Key: 312643478
• Report Number: 1119421-2023-00586
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 00380655093177
• UDI-Public: 00380655093177
• 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
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SN60WF
• Device Catalogue Number: SN60WF.190
• Device Lot Number: 15232098
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2023
• Date Manufacturer Received: 03/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• 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
• Patient Age: 81 YR
• Patient Sex: Male