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

Model Number	SA60WF
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/11/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation summary: the product was not returned for analysis.Product history and batch records were reviewed and documentation indicated the product met release criteria.The product investigation could not identify a root cause.There have been no other complaints reported in the lot number.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A nurse has reported that during five intraocular lens (iol) implant procedures, and after the insertion of the iol, debris was noted.The debris was cleared from the patients using i/a.The lenses were checked under the microscope prior to insertion into the eye, and no debris could be seen.Only after it was inserted into the eye could it be seen.The original procedure was completed in all instances and just a few minutes of extra time was used to ensure the debris had been cleared.There are five medical device reports associate with this physician.This report is associated with iol 2 of 5.
Additional Manufacturer Narrative
Product evaluation: the product and reported material were not returned.Two photos were provided.The distortion in the first photo made is difficult to see the reported material.An artifact is observed near the right edge.Unable to determine if the artifact is on or under the lens.The second photo has an elongated material at the 2 o¿clock position.The nature and origin of the material cannot be determined from the photo.Iol product history records were reviewed and documentation indicated the product met release criteria.A qualified cartridge was indicated.Product history records were reviewed for the potential cartridge lot numbers provided and documentation indicated the product met release criteria.The handpiece and viscoelastic used were not provided.It is unknown if qualified products were used.The product investigation could not identify a root cause for the reported complaint.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF ASPHERIC UV ABSORBING SINGLEPIECE IOL
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• MDR Report Key: 11602945
• Report Number: 1119421-2021-00712
• Device Sequence Number: 19732856
• Product Code: HQL
• UDI-Device Identifier: 00380652332699
• UDI-Public: 00380652332699
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 06/04/2021

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: 12/10/2025
• Device Model Number: SA60WF
• Device Catalogue Number: SA60WF.215
• Device Lot Number: 15120584
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/16/2021
• Supplement Date Received by Manufacturer: 05/17/2021
• Initial Report FDA Received Date: 04/01/2021
• Supplement Report FDA Received Date: 06/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D
• Patient Age: 67 YR