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

Model Number AU00T0

Device Problem Device Damaged by Another Device (2915)

Patient Problems Eye Injury (1845); Inflammation (1932); Blurred Vision (2137)

Event Date 08/01/2022

Event Type  Injury  

Event Description

A physician reported that during a cataract extraction with intraocular lens (iol) implant procedure, there was a scratch found on optic hence the lens was explanted.The doctor's opinion is that inflammation was caused by the procedure of iol removal in the initial surgery, and that the inflammation caused visual acuity decreased.The lens was replaced with another lens.

Manufacturer Narrative

The device and the lens were returned in the opened blister tray inside the opened carton.The lens was taped with surgical tape to the device exterior.Viscoelastic was dried on the lens.There were no scratches observed; however, the optic has small cracks that may have been interpreted as the reported complaint.The optic edge has a small broken area (returned).The optic was also split at the broken area and travelled across the optic center toward the opposite side of the lens.The device was returned with the lens stop and plunger lock removed.The plunger was oriented correctly.Viscoelastic was dried in the device.The plunger was retracted to mid-nozzle.The nozzle tip has heavy stress on all sides.The stress enlarged into an aneurysm along the posterior.The aneurysm extended to the end of the tip.The nozzle was removed and cleaned for further evaluation.The lens was removed during the cleaning.Top coat dye stain testing was conducted with acceptable results.Product history records were reviewed and documentation indicated the product met release criteria.Viscoelastic was not provided.It is unknown if the qualified product was used.The root cause could not be determined for the reported complaint.A scratch was not observed; however cracks and additional lens damage was observed.The cracked optic damage may have been interpreted as the reported complaint.The lens was returned outside of device.The plunger was retracted upon return.The plunger position in relation to the damaged lens during advancement cannot be determined.The tip damage suggests also the lens was not in the proper position for advancement.The instructions for use (ifu) instructs: after the lens has been advanced to the nozzle line, the lens should be visually inspected to determine the position of the haptics.The plunger should be in contact with the trailing optic edge.After confirming the lens is properly positioned and the haptics are folded properly, proceed with lens implantation.Proceeding with implantation of a misfolded haptic or a lens that appears to be ¿out of position¿ can result in a negative outcome, since the haptic may be trapped and stretched, and/or pinched and sheared by the moving plunger.It is unknown if a qualified viscoelastic was used.The instructions for use (ifu) instructs: during device preparation and implantation of the company intraocular lens (iol) with the company preloaded delivery system, a company qualified ophthalmic viscoelastic device (ovd) should be used.The use of an unqualified ophthalmic viscoelastic device (ovd) may cause damage to the lens and potential complications during the device preparation and implantation steps.Top coat dye stain testing was conducted with acceptable results.New information was received.The doctor's opinion is that inflammation was caused by the procedure of intraocular lens (iol) removal in the initial surgery, and that the inflammation caused visual acuity decreased.The patient is currently recovering.The doctor refused to provide any additional information.The manufacturer internal reference number is: (b)(4).

Event Description

Additional information was received stating incision was widen when explant intraocular lens during the initial surgery.

Manufacturer Narrative

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: 15570531
• MDR Text Key: 301825689
• Report Number: 1119421-2022-02150
• Device Sequence Number: 1
• Product Code: HQL
• 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: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AU00T0
• Device Lot Number: 15293015
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/29/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/15/2022
• Initial Date FDA Received: 10/10/2022
• Supplement Dates Manufacturer Received: 03/14/2023
• Supplement Dates FDA Received: 04/12/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other