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 Date 07/28/2022

Event Type  malfunction  

Manufacturer Narrative

The company device with the lens was returned loose in a bag.The plunger lock and lens stop were removed.The plunger was oriented correctly.Viscoelastic was observed in the device.The plunger has advanced the lens to mid-nozzle.The plunger was engaging the optic edge correctly.The optic was folded correctly.The trailing haptic was folded into the optic fold.The leading haptic was extended into the tip.The plunger, lens, and haptics were in acceptable positioned per the instructions for use (ifu).The straight leading haptic was most likely interpreted as a complaint.There was no damage observed to the sample.A photo was available in the file.The photo displayed the device n a plastic bag.No determination could be made based only on the photo.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 cannot be determined.No problems are observed with the returned device.A straight leading haptic was observed.The straight leading haptic was most likely interpreted as a complaint.The lens and haptic positions are acceptable.Straight leading haptics are not a product malfunction.This is an acceptable position per the diagrams provided in the ifu.It is unknown if a qualified viscoelastic was used.The 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.There was one other complaint in this lot.A straight leading haptic may occur: ¿ due to the normal folding variations as indicated the ifu diagrams.¿ if the initial plunger advancement is faster than the recommended target, the leading haptic may be forced past the internal folding feature.¿ if there is excessive delay between the device preparation and subsequent delivery the leading haptic may start to unfold.¿ if the operating room temperature is too high (> 23°c / 73° f) lens folding consistency is negatively affected, the lens is more adherent and this may inhibit lens advancement or contribute to incorrect haptic folding.Any of the above listed causes alone, or in combination, may create the reported event.The manufacturer internal reference number is: (b)(4).

Event Description

A non-healthcare professional reported that during an intraocular lens (iol) implant procedure, lens was defective.Additional information was requested.

• 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: 15751371
• MDR Text Key: 307184234
• Report Number: 1119421-2022-02378
• Device Sequence Number: 1
• Product Code: KYB
• UDI-Device Identifier: 00380652395311
• UDI-Public: 00380652395311
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P930014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/08/2022

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 Expiration Date: 10/27/2023
• Device Model Number: ACU0T0
• Device Lot Number: 15110452
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2022
• Initial Date Manufacturer Received: 10/14/2022
• Initial Date FDA Received: 11/08/2022
• Date Device Manufactured: 10/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1