MAUDE Adverse Event Report: ALCON LABORATORIES IRELAND LTD. ACRYSOF IQ NATURAL SINGLEPIECE IOL; INTRAOCULAR LENS

Model Number	SN60WF
Medical Device Problem Codes	Defective Device (2588); Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/27/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A physician reported that during the intraocular lens implant the surgeon noticed an anomaly on the surface of the lens while lens was in the eye bag.The doctor explained that it was an extra material like wire extended from the surface of the lens.The doctor tried to remove it with a forceps and with the aspiration and irrigation module, but with no result then the surgeon cut it and removed from the patients eye.The procedure was completed with the replacement lens.Additional information has been requested.
Additional Manufacturer Narrative
Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.Two photos received, photo shows an iol in the lens case base well, half of the iol is missing.Photos 2 shows an iol resting on the flat part of the lens case base outside of the well, half of the iol is missing.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
Half iol returned in iol case.Solution is dried on the iol.The remaining haptic is intact.The optic has surface fibers and is scratched/marked-rejectable.The sample was sent to particulate laboratory for testing.Comparison of the fibers¿ generated ir spectra to a library of spectra finds the best match to be wypall fibers (natural fibers).Two photos received, photo shows an iol in the lens case base well, half of the iol is missing.Photo 2 shows an iol resting on the flat part of the lens case base outside of the well, half of the iol is missing.The root cause for the reported complaint could not be determined.Based on the spectral comparison results, the returned fiber is wypall fiber (natural fiber).This is a commonly used material, including in medical products/environments.The product was subject to handling and the reported "foreign material" was highlighted post implantation.The origin of the observed foreign material could not be determined.No wypall paper is used in eca production areas.In addition to this, all iols are 100% cosmetically inspected as per approved manufacturing procedures and the observed fiber would not meet our current release criteria.Based on the results from the product history record, the products met release criteria.No further action is warranted at this time.Alcon will continue to monitor data for evidence of adverse trending and take further action, as appropriate.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF IQ NATURAL SINGLEPIECE IOL
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): ALCON LABORATORIES IRELAND LTD.; cork business&technology park; model farm road; cork 00000 ; EI 00000
• Manufacturer (Section G): ALCON LABORATORIES IRELAND LTD.; cork business&technology park; model farm road; cork 00000 ; EI 00000
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 18168691
• Report Number: 9612169-2023-00812
• Device Sequence Number: 6721647
• Product Code: HQL
• UDI-Device Identifier: 00380655093191
• UDI-Public: 00380655093191
• Combination Product (Y/N): N
• Initial Reporter Country: GR
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/16/2024

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 Model Number: SN60WF
• Device Catalogue Number: SN60WF.200
• Device Lot Number: 25459947
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 11/10/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/27/2023
• Supplement Date Received by Manufacturer: 01/22/2024
• Initial Report FDA Received Date: 11/20/2023
• Supplement Report FDA Received Date: 02/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/30/2022
• 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
• Patient Sex: Female