MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON ACRYSOF IQ NATURAL SINGLEPIECE IOL; INTRAOCULAR LENS

Model Number	SN60WF
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/17/2022
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 the cartridge did not advance and there was a patient contact.The surgery was completed on the same day with back up lens.Additional information will be requested.
Additional Manufacturer Narrative
The lens was returned in the nozzle entry area of a qualified company cartridge.An inadequate amount of viscoelastic was observed in the cartridge.Viscoelastic was observed in the cartridge tip only.The lens was pressed up instead of biased down per the instruction for use.Both haptics area misfolded adhered to the posterior side of the optic instead of the anterior.The extensive damage to the front wings may indicate a non-qualified handpiece was used.No tip damage observed.Complaint history and product history records were reviewed, and documentation indicated the product met release criteria.The file indicated the use of a qualified cartridge and a viscoelastic that is not qualified for the lens/cartridge combination used.The associated handpiece was not provided.It is unknown if a qualified product was used.Multiple requests for clarification have been sent.The facility is not giving any explanation as to what happened to the cartridge and/or clarification on what is meant by the phrase "the cartridge did not advance" as "cartridges" do not advance.The root cause for the reported event is most likely related to a failure to follow the instruction for use.The instruction for use instructs to bias the lens down before advancing the lens in the cartridge.Failure to follow this step may cause the lens to advance incorrectly causing delivery issues and/or damage.An inadequate amount of viscoelastic was observed in the cartridge.The instruction for use also instructs to completely fill the cartridge with ophthalmic viscosurgical device (ovd) immediately prior to loading and delivery of the lens.Do not attempt to load the lens without adequate ophthalmic viscosurgical device (ovd) in the device.Not adequately filling the device with viscoelastic will result in inadequate coverage of lens and the lens fold path with ophthalmic viscosurgical device (ovd), which may result in damage.In addition, a non-qualified viscoelastic combination was indicated and the extensive damage to the front wings may indicate a non-qualified handpiece was used.The instruction for use instructs that a company qualified delivery system and viscoelastic combination should be used.The use of an unqualified combination may cause damage to the lens and potential complications during the implantation process.Company recommends using the qualified company intraocular lens delivery system or any other company qualified combination.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF IQ NATURAL SINGLEPIECE IOL
• 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: 15427205
• Report Number: 1119421-2022-01956
• Device Sequence Number: 18020427
• Product Code: HQL
• UDI-Device Identifier: 00380655095744
• UDI-Public: 00380655095744
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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,Followup
• Report Date (Section B): 10/11/2022

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: 08/11/2026
• Device Model Number: SN60WF
• Device Catalogue Number: SN60WF.270
• Device Lot Number: 15240801
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/29/2022
• Supplement Date Received by Manufacturer: 09/16/2022
• Initial Report FDA Received Date: 09/15/2022
• Supplement Report FDA Received Date: 10/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/13/2021
• 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: MONARCH III IOL CARTRIDGE D; OCCUCOAT OVD
• Patient Age: 79 YR
• Patient Sex: Female