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

Model Number	SN60WF
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/07/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product was not returned for analysis; the lens remains implanted.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 non healthcare professional reported that during an intraocular lens (iol) implant procedure, the physician found a fragment/fiber in the anterior chamber of a patient after iol insertion.Physician had saved the fiber in the vial.Additional information was received and the lens was still in patient's eye.
Additional Manufacturer Narrative
Additional information was provided in d.9., h.3, h.6.And h.10.The lens, the lens case, lens carton and packaging components were not returned.A small clear specimen jar with a screw top lid was returned.The specimen jar was half filled with a clear liquid solution.Two small medical sponges in wedge shapes and fibers were also inside the liquid.The specimen jar containing the fluid, wedges, and fibers was sent to the particle lab for further analysis.The particle lab conducted analysis using microscopic examination and ft-ir methods.Per report ar no: s-20211022-03288.One (1) vial with solution and two swab returned.Reportedly, a fiber was observed.Results: the vial, solution and swabs were visually and microscopically examined.The contents of the vial was poured into a clean petri slide and the presence of a foreign material was confirmed.Microscopic examination shows a few white fibers up to 3.5 mm in length.No other long fibers were observed on the swabs.A representative white fiber was isolated and analyzed using microscopic fourier transform infrared spectroscopy (micro ft-ir).Comparison of the white fiber's generated ir spectra to a library of spectra finds the best match to be wypall fibers (paper).Product history records were reviewed and the documentation indicated the product met release criteria.Associated products were not provided.It is unknown if qualified products were used.The root cause cannot be determined for the reported complaint.A small vial was returned and sent for testing.Fibers were present inside the liquid filled container.A representative fiber was isolated and tested.Comparison of the white fiber's generated ir spectra to a library of spectra finds the best match to be wypall fibers (paper).Wypall are not used in the manufacturing environment.Wypall are a low lint product used in many surgical environments.It cannot be confirmed if the fiber originated from other products that may have been used in the surgery suite.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
• 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 ; 8175514979
• MDR Report Key: 12554361
• Report Number: 1119421-2021-01861
• Device Sequence Number: 4291380
• Product Code: HQL
• UDI-Device Identifier: 00380655095720
• UDI-Public: 00380655095720
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/12/2021

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: 03/15/2026
• Device Model Number: SN60WF
• Device Catalogue Number: SN60WF.155
• Device Lot Number: 15170511
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/30/2021
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/09/2021
• Supplement Date Received by Manufacturer: 11/16/2021
• Initial Report FDA Received Date: 09/30/2021
• Supplement Report FDA Received Date: 12/12/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/17/2021
• 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: MONARCH III IOL CARTRIDGE D; MONARCH III IOL INJECTOR; PROVISC; MONARCH III IOL CARTRIDGE D; MONARCH III IOL INJECTOR; PROVISC
• Patient Age: 66 YR
• Patient Sex: Male