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

Model Number	AU00T0
Medical Device Problem Code	Device Damaged by Another Device (2915)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/19/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A non health care professional reported that during surgery they have noticed that the lens was not in the good condition.Subsequently the lens was removed during initial procedure and completed with another lens with same diopter.Additional information has been requested.
Additional Manufacturer Narrative
The device was returned loose inside the carton.The lens stop and the plunger lock were removed.The plunger was oriented correctly.Viscoelastic was observed in the device.The plunger was advanced into the nozzle and was in contact with the trailing optic edge upon return.The leading haptic was extended.The trailing haptic was broken in the gusset area and was in front of the plunger, positioned to the left side of the optic leading edge.The distal haptic tip was oriented toward the device nozzle tip.Due to the position of the observed broken haptic and the condition of the plunger pressed against the trailing optic edge upon return, this may suggest that the plunger was retracted and advanced a second time.The nozzle was removed and cleaned for further evaluation.The lens was removed during the cleaning.Top coat dye stain testing was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 the documentation indicated the product met release criteria.Viscoelastic was not provided.It is unknown if the qualified product was used.The root cause for the broken haptic could not be determined.The broken haptic was in front of the plunger with the distal portion oriented toward the nozzle tip.The plunger was against the trailing optic edge upon return.This may suggest the plunger had been previously retracted and advanced prior to return.The plunger position in relation to the broken haptic during advancement cannot be determined.The haptic position may indicate the plunger was not fully advanced.If the plunger is not fully advanced the trailing haptic may not release properly from the device.It is unknown if a qualified viscoelastic was used.The instructions for use (ifu) instructs: during device preparation and implantation of 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.Broken haptics may occur due to the use of a non-qualified viscoelastic.The use of an unqualified ovd may cause damage to the lens and potential complications during the device preparation and implantation steps.If the operating room temperature is too high (23 degree celsius per 73 degree fahrenheit) lens folding consistency is negatively affected, the lens is more adherent and this may inhibit lens advancement.In addition, haptic strength (modulus) decreases as the temperature increases and is more likely to break under stress.If a straight trailing haptic occurs and it was not properly detected to be out of position.If the plunger is not fully advanced, or if the plunger is allowed to retract, the trailing haptic may not release properly from the device.Any of the above listed causes alone, or in combination, may create the reported event top coat dye stain testing was conducted with acceptable results.Information was provided that the company 19.5 diopter lens was replaced with an unknown 19.5 diopter lens.Due diligence has been performed in an attempt to obtain further information on this event.The reporter has not responded to request for follow-up information.File will be reopened if new information is received.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
Corrected information provided in d.4.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF IQ SINGLEPIECE IOL WITH ULTRASERT DELIVERY SYSTEM
• Common Device Name: 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: 20481368
• Report Number: 1119421-2024-02037
• Device Sequence Number: 20874452
• Product Code: KYB
• UDI-Device Identifier: 00380652394758
• UDI-Public: (01)00380652394758(17)250821(11)220823(10)15476686(21)15476686070
• Combination Product (Y/N): N
• Initial Reporter Country: PM
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 11/15/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/21/2025
• Device Model Number: AU00T0
• Device Lot Number: 15476686
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2024
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/20/2024
• Supplement Date Received by Manufacturer: 10/18/2024
• Initial Report FDA Received Date: 10/18/2024
• Supplement Report FDA Received Date: 11/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/23/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Male