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 Code	Ejection Problem (4009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/13/2022
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 healthcare professional reported during an intraocular lens implant procedure, the lens went into the eye backwards.Additional information has been requested which states there was no patient harm.
Event or Problem Description
Additional information has been received that the viscoelastic in the device had the appearance of a clear damaged iol.However, upon further review of the device and disassembly for testing the lens was not returned for this specific device.
Additional Manufacturer Narrative
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 fully advanced outside the nozzle tip.The lens was not returned.The nozzle was removed from the device for further evaluation.Top coat dye stain testing was conducted with acceptable results.Viscoelastic was not provided.It is unknown if a qualified product was used.The root cause for the reported issue could not be determined.The lens was originally reported to have been delivered "backwards".Follow-up information stated the lens was not implanted.However, the device was returned without the lens.The lens position upon delivery cannot be determined.No damage or abnormalities were observed with the device.The instruction for use (ifu) instructs: during device preparation and implantation of the iol with the 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 also instructs after the lens has been advanced to the ¿fill-to¿ 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.No part of the lens should exit the nozzle prior to insertion through the incision.Once the lens is in position at the ¿fill-to¿ line, it should be implanted within 3 minutes.If the leading haptic is straight or looped and extended in front of the lens, rotate device clockwise to be bevel left before advancing plunger to ensure the leading haptic is correctly placed in the capsular bag.As the leading haptic begins to exit the nozzle tip, place the leading haptic into the capsular bag in its correct orientation, and continue to slowly advance the plunger to deliver the lens.As the optic exits the nozzle, rotate the device counter clockwise back to center or slightly bevel right if needed to ensure the lens unfolds anterior side up within the capsular bag.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; 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: 14632600
• Report Number: 1119421-2022-01216
• Device Sequence Number: 3626226
• Product Code: HQL
• UDI-Device Identifier: 00380652395359
• UDI-Public: 00380652395359
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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
• Report Date (Section B): 08/19/2022

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: 11/10/2024
• Device Model Number: ACU0T0
• Device Lot Number: 15303685
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/17/2022
• Supplement Date Received by Manufacturer: 07/26/2022
• Initial Report FDA Received Date: 06/08/2022
• Supplement Report FDA Received Date: 08/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/12/2021
• 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 Age: 87 YR
• Patient Sex: Male