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

Model Number	MA60MA
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/07/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A product 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.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A nurse reported during intraocular lens (iol) implant procedure, the damaged lens was not implanted.The procedure was completed without any harm to the patient.Additional information has been requested.
Additional Manufacturer Narrative
Additional information was provided in h.3., h.6.And h.11.The sample was not returned.Photos were provided.Photo one displayed the lens being held by fine tipped tweezers.The lens was held posterior surface facing the camera.There appeared to be viscoelastic on the lens.The optic edge appeared to be broken in two areas.Photo two displayed the lens held anterior surface toward the camera.The optic edge was broken in two areas.One broken optic edge area included a portion of one of the haptic insertion areas.The areas of damage are similar in spacing and appearance to damage from posts of the lens case.Product history records were reviewed, and the documentation indicated the product met release criteria.Associated product information was not provided.It is unknown if qualified products were used.Based on the provided photos, the optic edge was broken in two areas.There appeared to be viscoelastic on the lens.It is difficult to make a determination of handling without evaluation of the physical sample.The spacing and damage to the optic edge appears similar in appearance to damage from posts of a lens case.If a lens becomes misaligned in the lens case, lens damage may occur.A physical sample would be necessary to make a final determination.A final root cause cannot be determined based on available information.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: 20613314
• Report Number: 1119421-2024-02150
• Device Sequence Number: 7353630
• Product Code: HQL
• UDI-Device Identifier: 00380650699299
• UDI-Public: (01)00380650699299(17)260913(11)210915(10)15260570
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• 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,Distributor
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 01/03/2025

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: 09/13/2026
• Device Model Number: MA60MA
• Device Catalogue Number: MA60MAN010
• Device Lot Number: 15260570
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/07/2024
• Supplement Date Received by Manufacturer: 12/11/2024
• Initial Report FDA Received Date: 11/05/2024
• Supplement Report FDA Received Date: 01/03/2025
• Date Device Manufactured: 09/15/2021
• 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: Male