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

Model Number SN6AT3

Device Problem Difficult to Advance (2920)

Patient Problem Insufficient Information (4580)

Event Date 01/27/2022

Event Type  malfunction  

Manufacturer Narrative

A sample device was not returned for analysis.Product history records were reviewed and documentation indicated the product met release criteria.Root cause has not been identified.There have been no other complaints reported in the lot number.The manufacturer internal reference number is: (b)(4).

Event Description

A surgeon reported that during an intraocular lens (iol) implant procedure, the lens was stuck in the cartridge.Procedure was completed with new lens and cartridge.Additional information has been requested.

Manufacturer Narrative

The lens was returned stuck in a qualified company device.The lens and cartridge were returned along with the disassembled lens case inside the opened carton.Inadequate viscoelastic was observed in the cartridge.The lens was located beyond the nozzle entry area.The lens was mispositioned inside the cartridge.The lens was posterior surface up with the posterior of the optic against the interior ceiling of the cartridge.The leading haptic was extended.The trailing haptic was folded and adhered onto the anterior optic surface.The cartridge was cleaned for further evaluation.The lens was removed during cleaning.Top coat dye stain testing was conducted with acceptable results.Information was provided that indicated the use of a qualified cartridge, handpiece, and viscoelastic combination.The root cause appears to be unrelated to the lens or cartridge.Information was provided that the patient moved and the surgeon was unable implant the lens because the lens was partially out of the cartridge.This would indicate that there wasn't an issue with the lens or cartridge.The surgeon had to reinsert and fold the lens back into the cartridge and on the second attempt the lens became stuck.It is unknown if the original cartridge was re-used.Re-using a single use cartridge would be against the instructions for use (ifu).Information was also provided that the nurse had to hold the head of the patient while the surgeon inserted the lens.According to the scrub nurse and surgeon, there wasn¿t any issue observed with the lens or the cartridge.The returned lens was mispositioned posterior surface up and stuck in the cartridge.The ifu instructs to completely fill the cartridge with ophthalmic viscoelastic devices (ovd) (diagram provided) 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 ovd, which may result in damage.The cartridge has stress prior to and beyond the parting line which suggests the lens may not have been in a proper position for advancement.The lens was returned positioned incorrectly, pressed up instead of biased down 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.Failure to follow this step may cause the lens to advance incorrectly causing delivery issues and/or damage.The lens should also be inserted anterior surface up.Top coat dye stain testing was conducted with acceptable results.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF IQ TORIC SINGLEPIECE IOL
• Type of Device: LENS, INTRAOCULAR, TORIC OPTICS
• 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: 13535449
• MDR Text Key: 285626875
• Report Number: 1119421-2022-00288
• Device Sequence Number: 1
• Product Code: MJP
• UDI-Device Identifier: 00380652249676
• UDI-Public: 00380652249676
• Combination Product (y/n): N
• Reporter Country Code: SN
• PMA/PMN Number: P930014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2024
• Device Model Number: SN6AT3
• Device Catalogue Number: SN6AT3.090
• Device Lot Number: 12707101
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: DUOVISC.; MONARCH III IOL, CARTRIDGE D.; VISCOAT.
• Patient Sex: Male