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

Model Number	ACU0T0
Medical Device Problem Codes	Break (1069); Failure to Advance (2524)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A health care professional reported with a description, plunger did not engage correctly and haptic was missing part of the haptic or broken.Additional information has been requested.
Additional Manufacturer Narrative
Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
Additional information was provided in h.3.,h.6 and h.11.The product was not returned.Product history records were reviewed and the documentation indicated the product met release criteria.Viscoelastic was not provided.It is unknown if a qualified product was used.The product investigation could not identify a root cause.It is unknown if a qualified viscoelastic was used.The instructions for use (ifu) instructs: during device preparation and implantation of the company intra ocular lens (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 (greater than 23 degree centigrade / 73 degree fahrenheit) lens folding consistency is negatively affected, the lens is more adherent and this may inhibit lens advancement.Any of the above listed causes alone, or in combination, may create the reported event.Broken haptics may occur: if the operating room temperature is too high (greater than 23 degree centigrade / 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 the device is overfilled with ovd as this can prevent the trailing haptic from being placed properly or move the lens out of position resulting in misfolding.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.Due diligence has been performed in an attempt to obtain further information on this event.The reporter responded that no additional information would be available.File will be reopened if the sample is received.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
Additional information was provided in d.9.,h.3.,h.6 and h.11.The device with the lens was returned inside the blister tray.The plunger lock and lens stop have been removed.The plunger was oriented correctly.An abundance of viscoelastic was observed in the device.The plunger has advanced the lens to mid nozzle.The plunger tip was correctly engaged to the trailing optic edge.A plunger override was not observed upon return.The lens was in a proper position for advancement.The trailing haptic was folded in onto the optic.The leading haptic was extended.The distal haptic tip was obscured from view in a large collection of dried viscoelastic.The nozzle was removed and cleaned for further evaluation.The lens was removed during cleaning.During cleaning and removal of the dried viscoelastic from the nozzle, it was observed that optic edge was split in two separate areas and the leading haptic tip was broken.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 information was not provided.It is unknown if a qualified viscoelastic was used.The complaint was reported as plunger did not engage correctly, haptic is missing part of the haptic or broken.The product was returned and evaluated.The plunger was engaged to the optic trailing edge upon return.During cleaning and removal of the viscoelastic from the nozzle, trailing optic edge damage and broken leading haptic tip damage was observed.This may suggest a previous plunger override had occurred resulting in the observed lens damage.The root cause for the reported complaint cannot be determined.It is unknown if a qualified viscoelastic was used.The instruction for use (ifu) instructs: during device preparation and implantation of the company intra ocular lens (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.An abundance of viscoelastic was observed.This may suggest that the device was overfilled.Per the ifu: fully insert the ovd cannula, perpendicular to the device, through the viscoelastic port, located in the lens stop portion of the device.Fill the device until ovd can be observed flowing to the fill to line on the nozzle tip, then retract the cannula.This will require approximately 0.2 ml of ovd.Only use an company ovd qualified for use with the company pre-loaded delivery system that has been allowed to come to the operating room temperature.The ifu instructs: take at least 7 seconds to gently fold the iol by advancing the plunger forward in one smooth, continuous motion until the front edge of the optic is even with the fill to line on the nozzle.Do not allow any portion of the lens to exit the nozzle tip.At this position the blue spring will contact the clear main body.It is important to not advance the plunger abruptly to fold the iol as improper folding and lens damage may occur.Plunger override may occur: due to rapid advancement faster than the ifu recommended 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 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 (greater than 23 degree centigrade / 73 degree fahrenheit) lens folding consistency is negatively affected, the lens is more adherent and this may inhibit lens advancement.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.Due diligence has been performed in an attempt to obtain further information on this event.The reporter responded that no further information can be obtained.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF IQ ASPHERIC UV ABSORBING IOLWITH ULTRASERT DELIVERY SYSTEM
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): ALCON RESEARCH, LLC - HUNTINGTON; 246 kyle lane; huntington WV 25702
• Manufacturer (Section G): ALCON RESEARCH, LLC - HUNTINGTON; 246 kyle lane; huntington WV 25702
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 21355142
• Report Number: 1119421-2025-00353
• Device Sequence Number: 20797006
• Product Code: HQL
• UDI-Device Identifier: 00380652395212
• UDI-Public: (01)00380652395212(17)270117(11)240119(10)15785899
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/30/2025

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: Lay User/Patient
• Device Model Number: ACU0T0
• Device Lot Number: 15785899
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/17/2025
• Supplement Date Received by Manufacturer: 03/13/2025; 07/08/2025
• Initial Report FDA Received Date: 02/11/2025
• Supplement Report FDA Received Date: 04/09/2025; 07/30/2025
• Date Device Manufactured: 01/19/2024
• 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