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	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/26/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A sample device was not returned for analysis, remained implanted in eye.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 government agency reported that during a cataract extraction with intraocular lens (iol) implant procedure, the doctor found white spot on the optical surface of the lens after implanted the lens.As the lens has been implanted into the patient's eye and the removal of the lens will cause greater harm to the patient, the operation will be continued for safety reasons.The adverse event may have an impact on the patient's vision.No additional information was requested.
Additional Manufacturer Narrative
A photo was provided of monitor screen showing a lens in the eye.The single-piece lens is partially unfolded with one haptic still folded across the edge of the optic.A whitish area is observed at the optic edge (7 o'clock).This rounded spot at the edge of the optic has the appearance damage.Unable to determine from the photo if the artifact is damage or a particle.The viscoelastic used as not provided.It is unknown if a qualified product was used.The root cause for the reported ¿spot¿ could not be determined.The use of an unqualified ovd (ophthalmic viscosurgical device) may cause damage to the lens and potential complications during the device preparation and implantation steps.The ifu instructs to fill the device until viscoelastic, at a minimum, can be seen flowing past the nozzle ¿fill-to¿ line (approximately 0.2ml room temperature ovd).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: 15348693
• Report Number: 1119421-2022-01893
• Device Sequence Number: 17450773
• Product Code: KYB
• UDI-Device Identifier: 00380652249300
• UDI-Public: 00380652249300
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 11/22/2022

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/24/2026
• Device Model Number: SN6CWS
• Device Catalogue Number: SN6CWS.245
• Device Lot Number: 15257406
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/08/2022
• Supplement Date Received by Manufacturer: 10/27/2022
• Initial Report FDA Received Date: 09/02/2022
• Supplement Report FDA Received Date: 11/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/26/2021
• 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
• Patient Age: 67 YR
• Patient Sex: Female