MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON ACRYSOF IQ SINGLEPIECE IOL W/ACRYSERT C DELIVERY SYSTEM; LENS, GUIDE, INTRAOCULAR

Model Number	SN6CWS
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	Visual Impairment (2138)
Date of Event	05/01/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A sample device was not returned for analysis.Complaint history and product history records were reviewed and documentation indicated the product met release criteria.Root cause has not been identified.A photo was provided which shows a yellow lens placed inside a the barrel of an ovd syringe.A note is visible in the photo with the patient information hand written on it.There have been no other complaints reported in the lot number.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A physician reported following an intraocular lens (iol) implant procedure, the patient complained several times postoperatively about poor visual acuity.As a result, surgeon decided to exchange the iol for the same type of lens and same diopter.The surgeon also suspects an irregularity on the anterior surface of the lens.Postoperative result was satisfactory.Additional information has been requested.
Additional Manufacturer Narrative
The lens was returned in a surgical syringe filled with a clear liquid.The lens was removed and cleaned with klrp for further evaluation.One haptic was broken in the gusset area (returned).The optic was cut into two portions, typical of insertion and removal.A power and resolution verification was conducted with the larger portion.The optical resolution is acceptable; lens meets specification for focal length equaling a 18.5 diopter lens.No lens issue observed.The product investigation could not identify a root cause for the reported complaint.The lens was returned.A power and resolution verification was conducted.Each lens is subjected to a 100% assessment of the power and optical resolution during the manufacturing process in order to determine acceptability per the lens model and diopter.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF IQ SINGLEPIECE IOL W/ACRYSERT C DELIVERY SYSTEM
• Common Device Name: LENS, GUIDE, INTRAOCULAR
• 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: 14877069
• Report Number: 1119421-2022-01428
• Device Sequence Number: 14701561
• Product Code: KYB
• UDI-Device Identifier: 00380652249188
• UDI-Public: 00380652249188
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted 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): 09/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2024
• Device Model Number: SN6CWS
• Device Catalogue Number: SN6CWS.185
• Device Lot Number: 12750108
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/07/2022
• Supplement Date Received by Manufacturer: 08/14/2022
• Initial Report FDA Received Date: 06/30/2022
• Supplement Report FDA Received Date: 09/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/17/2019
• 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: ACRYSOF IOL W/ACRYSERT DELIVERY SYSTEM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male