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

Model Number	SA60AT
Medical Device Problem Code	Scratched Material (3020)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/19/2022
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 no other complaints reported in the lot number.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A healthcare professional reported that during implantation of an intraocular lens (iol) the at the moment of implanting the lens, a line was visualized in the peripheral area of the lens under the microscope and removed the observed lens from the eye and re-insert another lens of the same model.The patient presented increased ocular pressure, which was controlled and, in the end, the iol was implanted.Additional information was requested and received regarding conmed and the patient symptoms were resolved and there was no patient harm.
Additional Manufacturer Narrative
There are two attached photos to the file.Photo1: this photo has indirect lighting and shows the lens anterior side up.The lens is laying on an unknown surface.A narrow dark line is observed it cannot be determined if this is a mark on the lens or the material it is laying on.No determination can be made without physical evaluation of the complaint sample.No determination could be made from the provided photo photo2: this photo has direct lighting and shows the lens posterior side up.The line observed in the first photo was not observed.No determination can be made without physical evaluation of the complaint sample.No determination could be made from the provided photo the file indicated the use of a qualified cartridge.Based on our observation of the attached photo, the reported scratch/mark on the lens could not be confirmed.The root cause for the reported complaint appears to be related to failure to follow the instructions for use (ifu).The file indicated the use of a viscoelastic that is not qualified for the product combination used.The 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.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF SINGLEPIECE 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: 15830836
• Report Number: 1119421-2022-02441
• Device Sequence Number: 20094745
• Product Code: HQL
• UDI-Device Identifier: 00380652555777
• UDI-Public: 00380652555777
• Combination Product (Y/N): N
• Initial Reporter Country: PE
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/19/2023

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: 08/30/2026
• Device Model Number: SA60AT
• Device Catalogue Number: SA60AT.185
• Device Lot Number: 15260846
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/25/2022
• Supplement Date Received by Manufacturer: 12/24/2022
• Initial Report FDA Received Date: 11/19/2022
• Supplement Report FDA Received Date: 01/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2021
• 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: BSS; METHYLCELLULOSE; MONARCH III IOL CARTRIDGE C
• Patient Age: 86 YR
• Patient Sex: Female