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

Model Number	MA60AC
Medical Device Problem Code	Particulates (1451)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/06/2021
Type of Reportable Event	Malfunction
Event or Problem Description
A nurse reported during an intraocular lens (iol) implant procedure, the surgeon found a fabric on the lens optic inside the eye.The surgeon decided to explant the lens and change to another new lens during the initial procedure.Additional information has been requested.
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 lens was returned in the lens case.A very small amount of viscoelastic and possibly blood was observed on the lens in spots.There were four areas where the viscoelastic was pooled on the posterior optic edge.The lens was microscopically examined in the lens case and removed for further evaluation.The optic surface, edges and the areas of dried viscoelastic were evaluated up to 400x magnification.No "fabric" or foreign material was observed.The qualified monarch ii (b) cartridge was not returned.The viscoelastic was not provided, it is unknown if a qualified product was used.Only a small amount of viscoelastic was observed on the lens, which may indicate an inadequate amount was placed in the cartridge.Company foldable iols are qualified for use with an company qualified delivery system (handpiece and cartridge) and ophthalmic viscosurgical device (ovd) combination.The use of an unqualified combination may cause damage to the iol and potential complications during the implantation process.The ifu also instructs to completely fill the cartridge with ovd (diagram provided) immediately prior to loading and delivery of the lens.Do not attempt to load the lens without adequate ovd in the device.Not adequately filling the device with viscoelastic will result in inadequate coverage of lens and the lens fold path with ovd, which may result in damage.The cartridge was not retuned to be evaluated for damage.There are no other complaints in this lot.Investigation has been completed based on current information.Based on our current tracking, there are no adverse trends for this reported complaint.No further action warranted at this time.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF MULTIPIECE 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: 12916131
• Report Number: 1119421-2021-02286
• Device Sequence Number: 5222836
• Product Code: HQL
• UDI-Device Identifier: 00380652552608
• UDI-Public: 00380652552608
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 03/11/2022

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: 10/31/2024
• Device Model Number: MA60AC
• Device Catalogue Number: MA60AC.240
• Device Lot Number: 12757604
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/07/2021
• Supplement Date Received by Manufacturer: 02/17/2022
• Initial Report FDA Received Date: 12/02/2021
• Supplement Report FDA Received Date: 03/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/21/2019
• 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 II IOL DELIVERY SYSTEM; MONARCH II IOL DELIVERY SYSTEM.; MONARCH III IOL DELIVERY SYSTEM, INJECTOR
• Patient Sex: Unknown