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	Dent in Material (2526)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/10/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A facility representative reported that during an intraocular lens (iol) implant procedure, they observed abnormal appearance closest to outer edge of the lens and observed after implant, subsequently, the lens was removed during initial procedure, procedure is completed with another lens.There was no patient harm reported.Additional information has been requested.
Additional Manufacturer Narrative
The used device was returned loose in a large biohazard bag with a specimen jar.The lens stop and plunger lock were removed.The plunger was oriented correctly.Viscoelastic was dried in the device.The plunger was fully advanced with the plunger extended beyond the device.The anterior flange was bent backward.The lens was returned separate from the device inside the plastic specimen cup.Solution was dried on the lens.The posterior optic surface has a deep scrape mark along the edge.The optic was cut into three portions.Both haptics were fully intact to the optic and undamaged.Product history records were reviewed and the documentation indicated the product met release criteria.A qualified viscoelastic was indicated.The optic has a deep scrape near the edge along the posterior surface.The root cause cannot be determined for the reported complaint.The used device and lens were returned separately.The lens was returned cut into three portions.This damage is similar in appearance to damage created to help remove a lens from the eye.The upper flange was bent.The upper flange may bend during lens advancement as it is flexible.This can result if a plunger over or underride occurs.Due to the optic damage being observed on the posterior surface and the presence of the bent upper flange, this suggests that a plunger underride may have occurred and resulted in the scrape mark on the optic.Plunger override or underride may occur: ¿ due to rapid advancement faster than the ifu recommend rate.¿ 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.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: 18056456
• Report Number: 1119421-2023-01851
• Device Sequence Number: 5954130
• Product Code: KYB
• UDI-Device Identifier: 00380652395281
• UDI-Public: 00380652395281
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/02/2023

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: 07/19/2026
• Device Model Number: ACU0T0
• Device Lot Number: 15683087
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/24/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/10/2023
• Initial Report FDA Received Date: 11/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/21/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: PROVISC
• Patient Age: 70 YR
• Patient Sex: Female