MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON ACRYSOF IQ SINGLEPIECE IOL WITH ULTRASERT DELIVERY SYSTEM; INTRAOCULAR LENS

Model Number AU00T0

Device Problems Failure to Eject (4010); Physical Resistance/Sticking (4012)

Patient Problem Insufficient Information (4580)

Event Date 11/24/2023

Event Type  malfunction  

Manufacturer Narrative

Evaluation summary: investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.The manufacturer internal reference number is: (b)(4).

Event Description

A healthcare professional reported that during an intraocular lens (iol) implant procedure, the lens moved very sluggishly and the plunger had to be pushed forward with force.The doctor couldn't place this lens in the eye.The procedure completed with the replacement lens.Additional information has been requested.

Manufacturer Narrative

The product was not returned.Product history records were reviewed and the documentation indicated the product met release criteria.Viscoelastic information was not provided.It is unknown if a qualified viscoelastic was used.The root cause for the reported complaint may be related to a failure to follow the instruction for use (ifu).Information indicated that ¿additional viscoelastic substance had to be added to the inserter, and it was refrigerated.".Per the instruction for use: do not attempt to add ophthalmic viscoelastic device (ovd) to the device after the lens stop has been removed or lens damage may result.Do not attempt to retract the plunger after the plunger lock has been removed or plunger damage may result.Take at least 7 seconds to gently fold the intra ocular lens (iol) by advancing the plunger forward in one smooth, continuous motion until the front edge of the optic is even with the ¿fill-to¿ line on the nozzle.Do not allow any portion of the lens to exit the nozzle tip.At this position the blue spring will contact the clear main body.It is important to not advance the plunger abruptly to fold the iol as improper folding and lens damage may occur.The file indicated that the additional viscoelastic that was added, was refrigerated.Per the ifu: only use an company ovd qualified for use with the company pre-loaded delivery system that has been allowed to come to the operating room temperature.It is unknown if a qualified viscoelastic was used.The ifu instructs: during device preparation and implantation of the company model iol with the company preloaded delivery system, an company qualified ovd should be used.The use of an unqualified ovd may cause damage to the lens and potential complications during the device preparation and implantation steps.Information was provided in the file follow up section that the customer does not agree to contact.The file has been completed based on available provided information.If the sample becomes available for evaluation, the file will be reopened and updated.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF IQ SINGLEPIECE IOL WITH ULTRASERT DELIVERY SYSTEM
• 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: 18396753
• MDR Text Key: 331374867
• Report Number: 1119421-2023-02218
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 00380652394734
• UDI-Public: 00380652394734
• Combination Product (y/n): N
• Reporter Country Code: FI
• PMA/PMN Number: P930014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AU00T0
• Device Lot Number: 15476719
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/18/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/25/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1