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	Failure to Eject (4010)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/01/2024
Type of Reportable Event	Malfunction
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).
Event or Problem Description
A health care professional reported that the plunger missed the lens to the right.Additional information has been requested.
Additional Manufacturer Narrative
Additional information has been provided.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 ifu instructs: during device preparation and implantation of the company lens 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.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 degree c / 73 degree f) 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.Topcoat dye stain testing was conducted with acceptable results due diligence has been performed in an attempt to obtain further information on this event.Information was provided that the reporter had no further information about the event.File will be reopened if new information or the sample is received.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Sample was discarded.
Additional Manufacturer Narrative
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 ifu instructs: during device preparation and implantation of the company lens 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.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 degree c / 73 degree f) 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.Due diligence has been performed in an attempt to obtain further information on this event.Information was provided that the reporter had no further information about the event.File will be reopened if new information or the sample 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; 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: 19475169
• Report Number: 1119421-2024-01081
• Device Sequence Number: 20561217
• Product Code: KYB
• UDI-Device Identifier: 00380652395205
• UDI-Public: (01)00380652395205(17)260819(11)230821(10)15702518(21)15702518051
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/04/2024

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: 08/19/2026
• Device Model Number: ACU0T0
• Device Lot Number: 15702518
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 07/03/2024; 09/05/2024
• Initial Report FDA Received Date: 06/06/2024
• Supplement Report FDA Received Date: 07/31/2024; 10/04/2024
• Date Device Manufactured: 08/21/2023
• 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