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

Model Number	SN60WF
Medical Device Problem Code	Particulates (1451)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/13/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complaint history and product history records were reviewed and documentation indicated the product met release criteria.Root cause has not been identified.There were no other complaints reported in the lot number.Additional information was requested.The manufacturer internal reference number is:(b)(4).
Event or Problem Description
A customer reported that during implantation of an intraocular lens (iol) a small metallic fragment on the anterior surface of one of the lens was noted.The foreign body was removed during the same procedure and the surgery was completed the same day.Additional information was requested.
Additional Manufacturer Narrative
Additional information provided in d.9, h.3, h.6 and h.10 the product was not returned.The lens remains implanted.A photo was provided of a small dark speck on a sponge tip.No determination as to the nature of the particle can be determined from the photo.The sponge tip was returned in a specimen cup.The sample was sent to the lab unopened.The swab was visually and microscopically examined and no obvious particles were observed.The swab, container and interior of the cap were thoroughly examined by two different lab analyst and no particles were observed.Qualified associated products were indicated.The root cause could not be determined.The lens remains implanted.Lab analysis of the returned container and swab could not find the small particle observed in the provided photo.No determination can be made as to the nature and origin the small speck observed in the photo.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF IQ NATURAL SINGLEPIECE IOL
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• MDR Report Key: 11805405
• Report Number: 1119421-2021-00996
• Device Sequence Number: 3481721
• Product Code: HQL
• UDI-Device Identifier: 00380655095744
• UDI-Public: 00380655095744
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/29/2021

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: 02/03/2025
• Device Model Number: SN60WF
• Device Catalogue Number: SN60WF.270
• Device Lot Number: 15020037
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2021
• Initial Date Received by Manufacturer: 04/19/2021
• Supplement Date Received by Manufacturer: 06/24/2021
• Initial Report FDA Received Date: 05/11/2021
• Supplement Report FDA Received Date: 06/29/2021
• 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 CARTRIDGE D; MONARCH III IOL INJECTOR; PROVISC; MONARCH III IOL CARTRIDGE D; MONARCH III IOL INJECTOR; PROVISC
• Patient Age: 55 YR