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

Model Number	SN60WF
Medical Device Problem Code	Material Discolored (1170)
Health Effect - Clinical Codes	Blurred Vision (2137); Vitreous Hemorrhage (2143)
Date of Event	04/20/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
A physician reported following the intraocular lens implantation the patient was well until 2020 when she had a right vitreous hemorrhage of uncertain origin which resolved completely with no loss of vision.She has not had yag capsulotomies.Va has remained between 6/6 to 6/9.The patient had complained of blurring of vision.On examination of her iols through the dilated pupil it was evident that the lens was very much yellower particularly the back surface of the lens where the sheet of yellow was present.New glasses would be made which improves vision to 6/7.5.Additional information has been requested.
Additional Manufacturer Narrative
A sample device was not returned for analysis.Complaint and product history records were reviewed and documentation indicated the product met release criteria.There have been no other complaints reported in the lot number.Root cause has not been identified.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
Six images were submitted and reviewed.Slit lamp images were with various apertures illuminating the iols through dilated pupils.The right eye images show what appear to be a more diffuse confluence where it is difficult to discern individual refractile bodies and a yellow appearance as reported.Associated products were not provided.It is unknown if qualified products were used.Only photos were available to view.It is difficult to make a final determination without evaluation of the physical sample.Information was provided in the file the lens was implanted in 2008.A director reviewed the provided photos.The following review was provided: the right eye images show what appear to be a more diffuse confluence where it is difficult to discern individual refractile bodies and a yellow appearance as reported.When refractile bodies such as microvacuoles occur within iols, numerous small reflections of light can occur.Depending upon the light spectrum, intensity and beam size of the slit lamp, the angle of incidence of that light, and the size and density of the microvacuoles and their distribution, the light passing back to the observer can appear slightly different in color.Numerous clinical factors can affect visual performance and the impact of microvacuoles on vision lacks consensus based on numerous studies.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: 14403975
• Report Number: 1119421-2022-01030
• Device Sequence Number: 20215740
• 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: 2008
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/15/2022

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2012
• Device Model Number: SN60WF
• Device Catalogue Number: SN60WF.190
• Device Lot Number: 10740392
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/20/2022
• Supplement Date Received by Manufacturer: 05/17/2022
• Initial Report FDA Received Date: 05/15/2022
• Supplement Report FDA Received Date: 06/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/16/2007
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 88 YR
• Patient Sex: Female