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	Insufficient Information (4580)
Date of Event	11/08/2022
Type of Reportable Event	Malfunction
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 one other complaints reported in the lot number.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A pharmacist reported with a description stating that, found faulty intraocular lens (iol).Additional information has been requested.
Additional Manufacturer Narrative
Only half the lens was returned, surgically taped to the non-serialized side of the lens case lid.Solution and adhesive was observed, on the lens.The optic was torn/split/cracked (possibly cut) in half.The other half of the lens was not returned for evaluation.Associated products were not provided.It is unknown, if qualified products were used.The company model is only qualified, for use in the company cartridge.The root cause could not be determined, for the reported complaint of ¿faulty lens¿.The specific lens issue was not specified.Damage to the lens was observed.While we are unable to determine, the root cause of the lens damage, our observation reasonably suggests, that it is not manufacturing related.Due to the presence of surgical solution and the condition of the returned sample, the damage is most likely, related to customer handling.Associated products were not provided.It is unknown, if qualified 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.Follow up attempts were made.No further information has been provided 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: 15904456
• Report Number: 1119421-2022-02548
• Device Sequence Number: 5200505
• Product Code: HQL
• UDI-Device Identifier: 00380650699275
• UDI-Public: 00380650699275
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/04/2023

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 Model Number: MA60MA
• Device Catalogue Number: MA60MA.040
• Device Lot Number: 15363445
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/09/2022
• Supplement Date Received by Manufacturer: 03/07/2023
• Initial Report FDA Received Date: 12/02/2022
• Supplement Report FDA Received Date: 04/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/10/2022
• 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