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

Model Number	MA60AC
Medical Device Problem Code	Scratched Material (3020)
Health Effect - Clinical Code	Visual Impairment (2138)
Type of Reportable Event	Serious Injury
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).
Event or Problem Description
A healthcare professional reported that following an intraocular lens (iol) implant procedure, patient came back for a follow-up visit and complained that their vision was compromised and upon investigation physician observed scratch on the lens.The iol was exchanged for same lens model and diopter following the initial implant procedure.Additional information has been requested.
Additional Manufacturer Narrative
The product was not returned.Product history records were reviewed and the documentation indicated the product met release criteria.Information was provided that a non-qualified cartridge and a non-qualified viscoelastic were used.The model is only qualified for use in the company cartridges.The root cause for the reported complaint was most likely related to a failure to follow the ifu.A non-qualified cartridge and viscoelastic combination was indicated.The ifu instructs: company foldable iols are qualified for use with an company qualified delivery system (handpiece and cartridge) and ophthalmic viscosurgical device (ovd) combination.The ifu instructs that an 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.Information was provided that the diopter lens was removed and replaced with the "same diopter follow up attempts were made for more information.No further information has been provided.If additional information or the sample becomes available, the file will be reopened and updated.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: 18474032
• Report Number: 1119421-2024-00062
• Device Sequence Number: 6426156
• Product Code: HQL
• UDI-Device Identifier: 00380652552622
• UDI-Public: 00380652552622
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2024
• Device Model Number: MA60AC
• Device Catalogue Number: MA60AC.250
• Device Lot Number: 12765658
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/13/2023
• Supplement Date Received by Manufacturer: 03/01/2024
• Initial Report FDA Received Date: 01/09/2024
• Supplement Report FDA Received Date: 03/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/12/2019
• 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: CENTURION VISION SYSTEM, ACCESSORY, HANDPIECE.; MONARCH III CARTRIDGE C.; NON-COMPANY VISCO-ELASTIC.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown