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 Codes	Inaccurate Delivery (2339); Device Damaged by Another Device (2915)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/25/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device and the lens were returned separated.The plunger lock and lens stop have been removed.The plunger is oriented correctly.Inadequate viscoelastic is observed in the device.The plunger has been retracted to the loading area.A large aneurysm is observed on the bottom of the nozzle tip.The nozzle was removed for further evaluation.Top coat dye stain testing was conducted with acceptable results.The lens was returned adhered to the outside of the device with viscoelastic.One haptic is broken-gusset and distal are (both pieces returned).The optic is cut into two pieces.One portion has a large scrape on the anterior surface, which may indicate a plunger override occurred.A qualified viscoelastic was indicated.The root cause for the reported event could not be determined.The lens was returned outside of the device.The plunger position in relation to the lens during advancement cannot be determined.The lens exhibited damage that would indicate a plunger override occurred.The nozzle tip damage would indicate the lens/plunger were not in acceptable positions for advancement.The dfu 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.Top coat dye stain testing was conducted with acceptable results.There are no other complaints in this lot.Investigation has been completed based on current information.No further action warranted at this time.Based on our current tracking, there are no adverse trends for this reported complaint and based on the findings the residual risk remains unchanged and at an acceptable level.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A facility representative reported that, lens jammed in preloaded delivery system and was implanted incorrectly.Lens was cut out and replaced with a new one.

• 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
• MDR Report Key: 12074591
• Report Number: 1119421-2021-01278
• Device Sequence Number: 14677073
• Product Code: KYB
• UDI-Device Identifier: 00380652395205
• UDI-Public: 00380652395205
• 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): 06/28/2021

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: 10/13/2023
• Device Model Number: ACU0T0
• Device Lot Number: 15105266
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/01/2021
• Initial Report FDA Received Date: 06/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DUOVISC VISCOELASTIC SYSTEM