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 Code	Defective Device (2588)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/18/2022
Type of Reportable Event	Malfunction
Event or Problem Description
A health professional reported that during an intraocular lens (iol) implant surgery upon insertion in to the patient eye, plastic residue was noticed.They had to explant the lens and insert a new one.Additional information received and stated that it felt and looked as if the lens grated as it went through the injector and then had ¿shavings¿ on the edge.Which tried to hose/ wash off but couldn¿t so did a lens exchange.
Additional Manufacturer Narrative
Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
The product was not returned.Product history records were reviewed and the documentation indicated the product met release criteria.A non-qualified viscoelastic was indicated.There are no other complaints in this lot.The root cause may be related to a failure to follow the ifu (instruction for use).A non-qualified viscoelastic was indicated.The ifu instructs: during device preparation and implantation of the company iol with the 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.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
Only the used device was returned inside the opened carton with some of the inner packaging components.The lens was not returned for an evaluation.The plunger lock and lens stop were removed.The plunger was oriented correctly.Viscoelastic was observed in the device.The beveled anterior tip of the nozzle was bent backward as if in contact with a hard surface.The interior coating appears to be disrupted at the damaged area of the nozzle tip exit.The lens was not returned for an evaluation of the reported "shavings on the edge".Based on information in the file and evaluation of the returned used device, the root cause may be related to a failure to follow the instruction for use (ifu).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.The manufacturer internal reference number is: 2022-17208.

• 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
• 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: 14159791
• Report Number: 1119421-2022-00799
• Device Sequence Number: 2847691
• Product Code: KYB
• UDI-Device Identifier: 00380652395199
• UDI-Public: 00380652395199
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• 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): 02/08/2023

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: 02/18/2024
• Device Model Number: ACU0T0
• Device Lot Number: 15152479
• 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: 03/24/2022
• Supplement Date Received by Manufacturer: 05/09/2022; 01/13/2023
• Initial Report FDA Received Date: 04/20/2022
• Supplement Report FDA Received Date: 06/06/2022; 02/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/18/2021
• 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: Z-HYALIN
• Patient Sex: Unknown