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

Model Number	SN60WF
Medical Device Problem Codes	Particulates (1451); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/13/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product was not returned.The lens remains implanted.Photos were provided.Clinical evaluation of the photos was provided by global quality customer affairs (gqca).Three slit lamp photos were submitted and reviewed.Two are of low magnification and show a non-dilated pupil.There appears to be extensive deposits upon the visible portion of the iol (intraocular lens) but little else can be ascertained due to the photo quality and small pupil.The remaining photo is post-dilation and is of good resolution and moderate magnification.It is a direct light vertical slit beam focused on the anterior surface of the iol.The photo is significant for diffuse particles that appear to be located upon the surface of the iol and coating the majority of the surface.While the etiology cannot be stated with certainty, the appearance and clinical presentation is not consistent with glistenings or lecog.The appearance is consistent with inflammatory deposits.However, there is no mention of inflammation seen in the anterior chamber nor any patient symptoms suggestive of inflammation.Product history records were reviewed and documentation indicated the product met release criteria.The product investigation could not identify a root cause for the reported issues.The lens remains implanted.Clinical review of the provided photos indicated that the appearance was not consistent with glistenings or lecog.While the etiology cannot be stated with certainty based on the photos, the appearance was consistent with inflammatory deposits.The file will be reopened if new information is provided.There are no other complaints in this lot.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A surgeon reported that following post-operative day one of an intraocular lens (iol) implant procedure, noticed white particles on the implanted lens and glistening.No patient harm reported.Additional information was requested.
Event or Problem Description
Additional information was requested and received stating the patient had no complaints, visual acuity was not affected and there was no requirement for lens explant.The patient had still glistening which can be seen on slit lamp.There were no ocular inflammation or any postoperative complications.
Additional Manufacturer Narrative
On initial mdr the method code of 4114 was an error.It should have been 4117 on the original mdr.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 ; 8007579780
• MDR Report Key: 13495742
• Report Number: 1119421-2022-00219
• Device Sequence Number: 4705682
• Product Code: HQL
• UDI-Device Identifier: 00380655093177
• UDI-Public: 00380655093177
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/16/2023

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: 04/30/2023
• Device Model Number: SN60WF
• Device Catalogue Number: SN60WF.190
• Device Lot Number: 12619577
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/17/2022
• Supplement Date Received by Manufacturer: 04/20/2023
• Initial Report FDA Received Date: 02/09/2022
• Supplement Report FDA Received Date: 05/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/18/2018
• 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: VISCOAT OPHTHALMIC
• Patient Sex: Unknown