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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/03/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Only half of the lens and a small cut portion were returned in the lens case.Viscoelastic was observed dried on the lens portions.The lens was swabbed with klrp to evaluate for damage.The optic portions have been cut into pieces.These portions were scratched and had chipped areas with material removed.This damage may have been interpreted as the report complaint.It cannot be determine any of this damage was present before the lens removal.Product history records were reviewed and documentation indicated the product met release criteria.Qualified associated products were indicated.The root cause for the reported "crystals on the lens" could not be determined.All lenses are 100% inspected for cosmetic attributes and the damage exhibited by the returned complaint sample would not have met company's release criteria.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
An inventory management specialist reported that during intraocular lens implant procedure, debris on lens was observed.Additional information was requested and received stating there were crystals on the optic, so the lens was explanted during the initial procedure and implanted with new lens.There was no patient harm.

• 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
• 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: 13667658
• Report Number: 1119421-2022-00400
• Device Sequence Number: 14821487
• Product Code: HQL
• UDI-Device Identifier: 00380652332750
• UDI-Public: 00380652332750
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/04/2022

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: 11/30/2023
• Device Model Number: SA60WF
• Device Catalogue Number: SA60WF.245
• Device Lot Number: 12671790
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2022
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/14/2022
• Initial Report FDA Received Date: 03/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/10/2018
• 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: MONARCH III INJECTOR; MONARCH III CARTRIDGE D; PROVISC OVD
• Patient Sex: Unknown