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

Model Number	MA60MA
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Event or Problem Description
A non-health care professional reported that during an intraocular lens (ol) implant procedure, they realized lens was broken.Additional information was requested, but no further information is available.
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.All product and batch history records are quality reviewed prior to product release.Associated products were not provided.It is unknown if qualified products were used.The company lens model is only qualified for use in the company cartridge.The product investigation could not identify a root cause for the reported complaint.The product was not returned to evaluate.Not enough information was provided to determine if qualified associated products were used.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.Haptic manufacturing is a validated process with multiple inspections to verify the quality of the produced haptic material.These inspections include a verification of the dimensional accuracy, tensile strength, flexibility and cosmetic appearance.The inspections ensure that the material meets all required specifications before it is allocated for use.Due diligence has been performed in an attempt to obtain further information on this event.The reporter has not responded to request for follow-up information.File will be reopened if new information or the sample is received.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: 19057932
• Report Number: 1119421-2024-00644
• Device Sequence Number: 6592834
• Product Code: HQL
• UDI-Device Identifier: 00380650699275
• UDI-Public: 00380650699275
• Combination Product (Y/N): N
• Initial Reporter Country: DR
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 06/05/2024

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: 09/26/2026
• Device Model Number: MA60MA
• Device Catalogue Number: MA60MA.040
• Device Lot Number: 15279770
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/12/2024
• Supplement Date Received by Manufacturer: 05/09/2024
• Initial Report FDA Received Date: 04/08/2024
• Supplement Report FDA Received Date: 06/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/28/2021
• 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
• Patient Sex: Unknown