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

Model Number	MA60AC
Medical Device Problem Code	Failure to Eject (4010)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/18/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported via reply card that the lens was damaged and was not implanted.Additional information has been requested and received stated that the lens got stucked in the applicator, there was no patient harm.The backup lens was opened and implanted instead.No further information available.
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
Associated products were not provided.It is unknown if qualified products were used.The lens model is only qualified for use in the company cartridges.It is unknown if qualified products were used.The instruction for use (ifu) 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 foldable iols are qualified for use with a company qualified delivery system (handpiece and cartridge) and ophthalmic viscosurgical device (ovd) combination.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: 16194287
• Report Number: 1119421-2023-00123
• Device Sequence Number: 12278530
• Product Code: HQL
• UDI-Device Identifier: 00380652552486
• UDI-Public: 00380652552486
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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): 03/08/2023

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: 02/27/2026
• Device Model Number: MA60AC
• Device Catalogue Number: MA60AC.180
• Device Lot Number: 15153285
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/21/2022
• Supplement Date Received by Manufacturer: 02/07/2023
• Initial Report FDA Received Date: 01/18/2023
• Supplement Report FDA Received Date: 03/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2021
• 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: NON-COMPONY CARTRIDGE; NON-COMPONY HANDPIECE
• Patient Sex: Unknown