MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON ACRYSOF IQ ASPHERIC UV ABSORBING IOLWITH ULTRASERT DELIVERY SYSTEM; LENS, GUIDE, INTRAOCULAR

Model Number ACU0T0

Device Problem Defective Device (2588)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Manufacturer Narrative

The product has not been returned to the manufacturing site.Product history records were reviewed and documentation indicated the product met release criteria.Root cause has not been identified.No other complaints reported in the lot.The manufacturer internal reference number is: (b)(4).

Event Description

A nurse reported that during procedure, on injection blue piece from the plunger was broken off and left in the eye.Additional information has been requested.

Manufacturer Narrative

Only photos were provided of the used device.It cannot be determined if viscoelastic was present in the device.Two photos show the used device mylar of the serial number and diopter.One photo shows a small blue artifact wrapped in medical tape.Another photo show the used device and what appears to be a broken posterior area of the plunger tip.Viscoelastic information was not provided.It is unknown if a qualified viscoelastic was used.The root cause cannot be determined for the reported complaint.Based on our observation, the plunger tip appears to be broken on the posterior.It is difficult to make a determination of handling / damage without evaluation of the physical sample.The presence of clinical solution in the device cannot be confirmed.The root cause was reported as "on injection blue piece from the plunger was broken off and left in the eye", however, the photo would suggest that a broken piece of plunger was removed.A final root cause cannot be determined based on available information.It is unknown if a qualified viscoelastic was used.The instruction for use (ifu) instructs: during device preparation and implantation of the company iq iol with the company preloaded delivery system, an 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.If the sample becomes available, the file will be reopened and updated.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF IQ ASPHERIC UV ABSORBING IOLWITH ULTRASERT DELIVERY SYSTEM
• Type of Device: LENS, GUIDE, INTRAOCULAR
• 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: 15528402
• MDR Text Key: 301033629
• Report Number: 1119421-2022-02116
• Device Sequence Number: 1
• Product Code: KYB
• UDI-Device Identifier: 00380652395304
• UDI-Public: 00380652395304
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 12/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ACU0T0
• Device Lot Number: 15400513
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/09/2022
• Initial Date FDA Received: 10/03/2022
• Supplement Dates Manufacturer Received: 11/14/2022
• Supplement Dates FDA Received: 12/09/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/29/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1