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	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/03/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A healthcare professional reported with that during the intraocular lens (iol) implant procedure, the nurse was not able to fill the chamber of the cartridge with viscoelastic.The chamber was blocked.But the viscoelastic kept coming outside through the inlet.The surgery completed with backup lens.There was no patient impact.
Additional Manufacturer Narrative
A product 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.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
The device with the lens was returned inside the opened carton.The plunger lock and lens stop were intact.The plunger was oriented correctly and was at the starting point of the device barrel.Viscoelastic was observed in the device.A collection of dried viscoelastic was observed in the nozzle tip just past the wound guard.The lens was in the loading area.The lens stop was removed to further evaluate.The lens showed no signs of advancement.Viscoelastic was dried on the lens.The cannula guide (port) was not blocked.The body of the device was not blocked by any foreign material or device malformation.The only blocked area was the collection of viscoelastic dried in the nozzle tip of the device.Product history records were reviewed and documentation indicated the product met release criteria.A non-qualified viscoelastic was indicated.The cannula guide port opening and the device body were not blocked.A collection of dried viscoelastic was observed in the nozzle tip.This large collection of dried viscoelastic closed off the exit at the tip and may have been interpreted as the reported complaint of the chamber was blocked.The root cause may be related to a failure to follow the instructions for use (ifu).A non-qualified viscoelastic was used.The ifu instructs: during device preparation and implantation of the company iol with the 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.No malformation or damage of the product was observed.The lens was in the loading area.File will be reopened if new information is received.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: 20635044
• Report Number: 1119421-2024-02165
• Device Sequence Number: 20705098
• Product Code: HQL
• UDI-Device Identifier: 00380652395243
• UDI-Public: (01)00380652395243(17)270207(11)240209(10)15796320
• 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
• Report Date (Section B): 12/20/2024

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 Model Number: ACU0T0
• Device Lot Number: 15796320
• 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: 10/11/2024
• Supplement Date Received by Manufacturer: 11/22/2024
• Initial Report FDA Received Date: 11/07/2024
• Supplement Report FDA Received Date: 12/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/09/2024
• 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: OPTHEIS BIO
• Patient Sex: Female