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

Model Number	ACU0T0
Medical Device Problem Codes	Device Damaged by Another Device (2915); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/27/2022
Type of Reportable Event	Malfunction
Event or Problem Description
A physician reported with a description of the leading haptic was straight out in front of the iol (intraocular lens) at the beginning of the nozzle of the delivery system and not folded.The rear haptic appeared to be folding forwards correctly, but the iol appeared to be opened out and potentially not folding into the nozzle of the delivery system correctly.There appeared to be some damage starting at the rear of the iol that had been caused by the plunger.
Additional Manufacturer Narrative
A sample device was not returned for analysis.Complaint history and product history records were reviewed and documentation indicated the product met release criteria.Root cause has not been identified.There have been no other complaints reported in the lot number.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
Additional information provided in d.9., h.3., h.6., and h.10.The device with the lens was returned inside the opened blister tray inside the opened carton.The lens stop and plunger lock were removed.The plunger was oriented correctly.Viscoelastic was observed in the device.The plunger was retracted into the loading area.The lens was located in the nozzle area.The leading haptic was in a straight position.This position is acceptable per the ifu (instructions for use).The trailing haptic was positioned on the anterior optic surface.The distal area of the trailing haptic was broken.The broken tip was oriented toward the nozzle area which may suggest the distal tip area had looped over or across the plunger tip during delivery attempt.The trailing optic edge was torn by the advancing plunger.The nozzle was removed and cleaned for further evaluation.The lens was removed during cleaning.Top coat dye stain testing was conducted with acceptable results.Viscoelastic information was not provided.It is unknown if a qualified viscoelastic was used.The root cause cannot be determined for the reported complaint of straight leading haptic and lens damaged in delivery system.The optic was broken at the trailing edge.The trailing haptic was misfolded and broken onto the optic.The root cause for the misfolded trailing haptic cannot be determined.Haptic folding may be influenced by an intermittent plunger rate or if the operating room temperature is too high (> 23°c / 73° f).If the operating room temperature is too high lens folding consistency is negatively affected as the lens more adherent.This may inhibit lens advancement or contribute to incorrect haptic folding.The broken trailing optic edge and broken trailing haptic suggest that a plunger override may have occurred during the delivery attempt.It is unknown if a qualified viscoelastic was used.The ifu instructs: during device preparation and implantation of the company 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.Plunger override may occur: due to rapid advancement faster than the ifu recommend rate.Due to the use of a non-qualified viscoelastic.Material properties of non-qualified.Ovds may contribute to underfill, overfill, misfolding of the haptics, or other inconsistent folding outcomes.If inadequate viscoelastic is placed in the device this will cause inadequate coverage of the lens fold path which may cause the lens to advance incorrectly or become ¿stuck¿ in the device allowing the plunger to override the lens.If the device is overfilled with ovd, this can prevent the trailing haptic from being placed properly or move the lens out of position resulting in misfolding.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.A straight leading haptic was also observed.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 acrysof¿ iq iol with the ultrasert¿ preloaded delivery system, an alcon 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.Top coat dye stain testing was conducted with acceptable results.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.Due to the use of a non-qualified viscoelastic.Material properties of non-qualified ovds may contribute to underfill, overfill, misfolding of the haptics, or other inconsistent folding outcomes.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).

• Brand Name: ACRYSOF IQ ASPHERIC UV ABSORBING IOLWITH 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: 15650194
• Report Number: 1119421-2022-02249
• Device Sequence Number: 14085931
• Product Code: KYB
• UDI-Device Identifier: 00380652395342
• UDI-Public: 00380652395342
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/28/2023

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: 01/31/2025
• Device Model Number: ACU0T0
• Device Lot Number: 15344048
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/29/2022
• Supplement Date Received by Manufacturer: 03/03/2023
• Initial Report FDA Received Date: 10/21/2022
• Supplement Report FDA Received Date: 03/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/02/2022
• 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: Unknown