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 Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/22/2022
Type of Reportable Event	Malfunction
Event or Problem Description
A healthcare professional reported a series of faulty lens.Additional information was received that, during implantation of the lens, the lens haptic stuck to the injector.The lens was cut with scissors and surgically removed from the patient through the initial incision.Patient's contact was involved and surgical time went longer.
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).
Additional Manufacturer Narrative
The product was not returned.A non-qualified viscoelastic was indicated.The root cause may be related to a failure to follow the direction for use (dfu).The instructions for use (ifu) instructs: during device preparation and implantation of the company iol with company preloaded delivery system, an 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.Lens may become stuck in the device: if inadequate viscoelastic is placed in the device this will cause inadequate coverage of the lens fold path which may cause the lens to become ¿stuck¿ in the device.Due to the use of a non-qualified viscoelastic.Material properties of non-qualified ovds may contribute to underfill, overfill, misfolding of the haptics, or other inconsistent folding outcomes.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).
Additional Manufacturer Narrative
The used device with a portion of a broken haptic was returned loose in a large drawstring plastic bag.The plunger lock and lens stop were removed.The plunger was oriented correctly.Viscoelastic was observed in the device.The plunger was almost fully advanced.The broken portion of haptic was located in the plunger groove on the left side of the plunger (correct).The broken haptic portion was observed in the device at the nozzle tip.This haptic appeared to be the mid-section of the trailing haptic.The haptic tip extended outside the device and was cut off.The nozzle tip has heavy stress lines.The remainder of the lens was not returned.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.Root cause: a broken trailing haptic was observed stuck in the nozzle tip of the device.The plunger was not fully advanced upon return.If the device is overfilled with ovd as this can prevent the trailing haptic from being placed properly or move the lens out of position resulting in misfolding.¿ if a straight trailing haptic occurs and it was not properly detected to be out of position.If the plunger is not fully advanced, or if the plunger is allowed to retract, the trailing haptic may not release properly from the device.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: 14496636
• Report Number: 1119421-2022-01125
• Device Sequence Number: 6018979
• Product Code: HQL
• UDI-Device Identifier: 00380652395182
• UDI-Public: 00380652395182
• 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,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/10/2023

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: 04/28/2024
• Device Model Number: ACU0T0
• Device Lot Number: 15191823
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/29/2022
• Supplement Date Received by Manufacturer: 06/29/2022; 01/19/2023
• Initial Report FDA Received Date: 05/25/2022
• Supplement Report FDA Received Date: 07/28/2022; 02/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/30/2021
• 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: VISCOELASTIC: Z-HYALIN
• Patient Sex: Unknown