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	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/20/2022
Type of Reportable Event	Malfunction
Event or Problem Description
A government agency reported that during a cataract extraction with intraocular lens (iol) implant procedure, a crack was found on optical part of iol after implanted in the patient 's eye, then the iol was removed immediately.The surgery was completed after a new replacement was used.No additional information was requested.
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.There has been one other complaints reported in the lot number.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: 15461576
• Report Number: 1119421-2022-02016
• Device Sequence Number: 17224070
• Product Code: KYB
• UDI-Device Identifier: 00380652249324
• UDI-Public: 00380652249324
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 09/21/2022

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: 06/28/2026
• Device Model Number: SN6CWS
• Device Catalogue Number: SN6CWS.255
• Device Lot Number: 15224693
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/25/2022
• Initial Report FDA Received Date: 09/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/30/2021
• 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: 11 YR
• Patient Sex: Male