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 Codes	Failure to Fold (1255); Defective Device (2588); Failure to Eject (4010)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/25/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A sample device was not returned for analysis.Complaint history and product history records were reviewed, and documentation indicated the product met release criteria.Root cause has not been identified.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-health professional reported that during a cataract extraction with intraocular lens (iol) implant procedure, the lenses seem to be too hard and were not coming out in the correct position.Additional information was received stating the tip of the lens dispenser came into contact with the patient but there was no harm done to the patient.In regard to lenses not coming out in the correct position, we received clarification and it refers to the lenses would get stuck on the tip of the delivery device and then go back in, surgeon assumes it¿s because the lenses were not folding properly or the lenses were too hard.All procedures were done with back-up lenses.There are three medical device reports associated with this event.This report is associated with the 3 of 3.
Additional Manufacturer Narrative
Additional information provided in d.9., h.3., h.6.And h.10.The device with the lens was returned loose in the opened carton.The plunger lock and lens stop have been removed.The plunger was oriented correctly.Viscoelastic was observed in the device.The plunger was located at mid-nozzle and has overrode the lens.The lens was advanced halfway between the loading area and the nozzle entry area.The trailing haptic was folded onto the optic along the left side of the plunger.The leading haptic was extended along the right side of the device on the right of the plunger.The nozzle was removed and cleaned for further evaluation.The lens was removed during cleaning.Top coat dye stain testing was conducted with acceptable results.After the lens was removed from the device and all remaining viscoelastic, the lens relaxed into its original shape.The lens and haptics were pliable using tweezers.A fold test was conducted using folding tweezers.The lens folded and unfolded with no abnormalities observed.A qualified viscoelastic was indicated.A plunger override was observed.The plunger override and position of the lens was most likely interpreted as the reported complaint.The root cause cannot be determined for the reported complaint.The lens was halfway between the loading area and the nozzle entry.The plunger was advanced to mid-nozzle.Plunger override may occur: due to rapid advancement faster than the instruction for use (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 ophthalmic viscosurgical devices (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.Top coat dye stain testing was conducted with acceptable results.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: 15278066
• Report Number: 1119421-2022-01827
• Device Sequence Number: 15065481
• Product Code: HQL
• UDI-Device Identifier: 00380652395373
• UDI-Public: 00380652395373
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/25/2022

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: 02/24/2024
• Device Model Number: ACU0T0
• Device Lot Number: 15152501
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/28/2022
• Supplement Date Received by Manufacturer: 11/29/2022
• Initial Report FDA Received Date: 08/23/2022
• Supplement Report FDA Received Date: 12/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/25/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: PROVISC
• Patient Sex: Unknown