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 Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A product 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.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A non healthcare professional reported that during an intraocular lens (iol) implant procedure the lens haptic was broken in delivery system.The lens haptic (leading) detached from iol on attempt at insertion· the lens and introducer were then removed and forceps used to retrieve the haptic.The procedure was completed with replacement lens.Additional information has been requested.
Additional Manufacturer Narrative
The product was not returned.Product history records were reviewed and the documentation indicated the product met release criteria.A non qualified viscoelastic was indicated.The account indicated the use of a handpiece.It is unknown if the lens was loaded into a cartridge and delivered with the indicated handpiece.The handpiece indicated is not qualified for use with this lens, with any qualified lens cartridge combination.The root cause may be related to a failure to follow the instructions for use (ifu).A non-qualified viscoelastic was used in the device.The 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 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.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 (more than 23 degree c or 73 degree f) 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.The product has not been received to evaluate.Due diligence has been performed in an attempt to obtain further information on this event.The reporter has not responded to requests for follow up information.File will be reopened if new information or the sample is received.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
Only the device was returned.The plunger lock and lens stop were removed.The plunger was oriented correctly.Viscoelastic was observed in the device.The plunger was advanced to mid-nozzle.No damage was observed.The lens was not returned.Product history records were reviewed and the documentation indicated the product met release criteria.A non-qualified viscoelastic was indicated.The account indicated the use of a handpiece.It is unknown if the lens was loaded into a cartridge and delivered with the indicated handpiece.The handpiece indicated is not qualified for use with this lens, with any qualified lens / cartridge combination.The root cause may be related to a failure to follow the instructions for use (ifu).A non-qualified viscoelastic was used in the device.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.Broken haptics may occur: 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 (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 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 has not responded to requests for follow-up information.File will be reopened if new information is received.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; 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: 21880555
• Report Number: 1119421-2025-01123
• Device Sequence Number: 15638906
• Product Code: KYB
• UDI-Device Identifier: 00380652395311
• UDI-Public: (01)00380652395311(17)270501(11)240502(10)15848117
• 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,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/11/2025

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: Health Professional
• Device Model Number: ACU0T0
• Device Lot Number: 15848117
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/25/2025
• Supplement Date Received by Manufacturer: 05/21/2025; 06/18/2025
• Initial Report FDA Received Date: 04/22/2025
• Supplement Report FDA Received Date: 06/12/2025; 07/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/02/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: HANDPIECE USED: B+L.; OVD: OPHTEIS BIO 1.6.
• Patient Sex: Unknown