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 Codes	Break (1069); Optical Decentration (1360); Failure to Eject (4010)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/30/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product was not returned for analysis; the lens remains implanted.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 with a description of the haptic and injector had a problem at the time of intraocular lens implantation, resulting in an off center and lens malfunction.Additional information has been received and stated that the intraocular lens haptic got stuck in the cartridge and broke.The lens was implanted, but with the broken haptic , the lens implanted in a capsular bag but its off center.The explantation of lens was planned, yet not scheduled.
Additional Manufacturer Narrative
The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
The product was not returned.A photo was provided.The photo was of a computer screen.An eye was pictured.What appeared to be the edge of an iol was visible shifted downward in the center.No determination of cause could be made from the photo.Product history records were reviewed and documentation indicated the product met release criteria.A non qualified viscoelastic was indicated.The product was not returned for evaluation.The root cause for the reported broken haptic may be related to a failure to follow the instructions for use (ifu).A non qualified viscoelastic was indicated.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.The ifu instructs to 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.The ifu instructs after the lens has been advanced to the nozzle line, the lens should be visually inspected to determine the position of the haptics.The plunger should be in contact with the trailing optic edge.After confirming the lens is properly positioned and the haptics are folded properly, proceed with lens implantation.Proceeding with implantation of a misfolded haptic or a lens that appears to be out of position can result in a broken haptic or other negative outcome, since the haptic may be trapped and stretched, and or pinched and sheared by the moving plunger.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 (morethan23degreesc or 73degrees 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 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: 20357451
• Report Number: 1119421-2024-01942
• Device Sequence Number: 20635240
• Product Code: KYB
• UDI-Device Identifier: 00380652394543
• UDI-Public: (01)00380652394543(17)270101(11)240103(10)15775938(21)15775938070
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/29/2024

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 Model Number: AU00T0
• Device Lot Number: 15775938
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/03/2024
• Supplement Date Received by Manufacturer: 10/03/2024; 11/01/2024
• Initial Report FDA Received Date: 10/03/2024
• Supplement Report FDA Received Date: 10/29/2024; 11/29/2024
• Date Device Manufactured: 01/03/2024
• 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: Z HYALIN OVD.
• Patient Sex: Unknown