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

Model Number AU00T0

Device Problems Defective Component (2292); Device Damaged by Another Device (2915); Failure to Eject (4010)

Patient Problem Insufficient Information (4580)

Event Date 09/05/2023

Event Type  malfunction  

Event Description

A health care professional reported with a description of inserter was too loose and the intraocular lens (iol) slip out on its own.Additional information has been requested, received and stated the surgery was completed with another lens.Information has been received about the serial number of the lens.

Manufacturer Narrative

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).

Manufacturer Narrative

Correction information provided in h.6.(f24 not added previously in initial mdr reported).The product was not returned.Product history records were reviewed and the documentation indicated the product met release criteria.Viscoelastic was not provided.It is unknown if a qualified product was used.The product investigation could not identify a root cause for the reported "inserter is too loose and lens slips out on its own".The product has not been received to evaluate.The plunger tip of the company device is allowed to move side to side in the shipping position, to avoid damage during shipping and storage.After initial advancement, and prior to contacting the lens, the plunger is automatically directed along its central path, and there is no excess side to side movement.The plunger may have been inadvertently retracted outside of the device.Per the directions for use (dfu), do not attempt to retract the plunger after the plunger lock has been removed or plunger damage may result.Retracting the plunger can pull the tabs outside of the barrel and cause the plunger to release from the device.The instructions for use (ifu) instructs: during device preparation and implantation of the company iol with the company preloaded delivery system, a company qualified ophthalmic viscoelastic device (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.Follow up attempts were made.No further information has been provided at this time.File will be reopened when new information or the product is received.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: 18381285
• MDR Text Key: 331199709
• Report Number: 1119421-2023-02190
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 00380652394772
• UDI-Public: 00380652394772
• 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: 03/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2023
• 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: 15343825
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/13/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1