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

Model Number AU00T0

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem Foreign Body In Patient (2687)

Event Date 07/06/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

A customer reported that following an intraocular lens (iol) implant procedure, a piece of foreign material in the shape of a thread in a transparent color was seen in the eye.The surgeon hypothesized that it was a piece of plastic fiber belonging to the tip of cartridge.The surgery was performed and completed without product replacement.Foreign material remains in the eye however no surgery was planned because vision was good.Additional information received on 19 jul 2021.The surgeon reported that, foreign material was visually observed.Foreign material was aspirated by irrigations and aspiration and a surgeon thought that it was removed.However, the foreign material remained in iris seemingly.

Manufacturer Narrative

A photo was provided of the eye.What may be a fiber can be observed in the front of the eye.The origin of the possible fiber cannot be determined from the photo.Two viscoelastics were indicated.Both viscoelastics are qualified for use with the device.Based on our observation of the attached photo, there appeared to be possibly a fiber in the front of the eye.The origin of the possible fiber cannot be determined from the photo.It is difficult to make a final determination without evaluation of the physical sample.Information was provided by the customer that foreign material remains in the eye but no surgery will be planned because visual acuity is good.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF IQ SINGLEPIECE IOL WITH 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 ; 8175514979
• MDR Report Key: 12280088
• MDR Text Key: 265141629
• Report Number: 1119421-2021-01519
• Device Sequence Number: 1
• Product Code: KYB
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P930014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/01/2021

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 Expiration Date: 04/28/2023
• Device Model Number: AU00T0
• Device Lot Number: 15060576
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/08/2021
• Initial Date FDA Received: 08/05/2021
• Supplement Dates Manufacturer Received: 09/09/2021
• Supplement Dates FDA Received: 10/01/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: PROVISC OPHTHALMIC VISCOSURGICAL DEVICE; VISCOAT OPHTHALMIC VISCOSURGICAL DEVICE
• Patient Age: 74 YR