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	Failure to Unfold or Unwrap (1669)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/18/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Only the device was returned loose in a large biohazard bag.The plunger was oriented correctly in the device.The plunger lock and lens stop were removed.Viscoelastic was observed in the device.A reddish colored solution was also observed on the tip of the plunger and inside the nozzle tip of the device.The plunger was retracted to mid-nozzle.The nozzle posterior right side has an aneurysm that has extended as it travelled through the thick nozzle cone wall and into the thinner nozzle tip area.The aneurysm widened and the material inside the aneurysm has folded.The nozzle tip of the device has heavy stress lines.Product history records were reviewed and the documentation indicated the product met release criteria.A qualified viscoelastic was indicated.The root cause could not be determined for the reported complaint of "lens came out of injector and would not unfold".The lens was not returned.Only the used device was returned for an evaluation.Damage was observed to the device nozzle, which extends through the wound guard and into the tip.This type of damage is typically progressive and worsens as the lens is advanced.The damage on the posterior right side of the nozzle started prior to the thick wall cone area of the nozzle.Unusually high internal forces would be needed to create damage in this area.The two distinct areas of damage would indicate a progressive change that occurred as the lens was advanced.This type of damage typically occurs if the lens/plunger is not positioned correctly for advancement.The instruction for use (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.There have been no other complaints reported in the lot number.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A non-healthcare professional reported that during the cataract surgery with intraocular lens implant procedure, lens came out of injector and would not unfold.There was patient contact noted and procedure was completed on the same day.

• 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: 16378490
• Report Number: 1119421-2023-00327
• Device Sequence Number: 17692475
• Product Code: HQL
• UDI-Device Identifier: 00380652395359
• UDI-Public: 00380652395359
• 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): 02/15/2023

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: 03/05/2025
• Device Model Number: ACU0T0
• Device Lot Number: 15360738
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/25/2023
• Initial Report FDA Received Date: 02/15/2023
• Date Device Manufactured: 03/07/2022
• 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: DUOVISC
• Patient Age: 65 YR
• Patient Sex: Female