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

Model Number	SN6AT4
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Capsular Bag Tear (2639)
Date of Event	01/23/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product was not returned.Product history records were reviewed and documentation indicated the product met release criteria.Associated products were not provided.It is unknown if qualified associated products were used.The product investigation could not identify a root cause for the reported complaint.The product was discarded by the reporter.No delivery issues were reported.It is unknown if qualified associated products were used.The ifu instructs that an company qualified delivery system and viscoelastic combination should be used.The use of an unqualified combination may cause damage to the lens and potential complications during the implantation process.Information was provided by the surgeon that with careful reflection, they can not be certain the lens was to blame for the complication.The lens was explanted and disposed off.Surgeon asked to withdraw the complaint.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A healthcare professional reported that, during intraocular lens implantation surgery, a tear was noticed at the posterior capsule after the lens implantation.Hence the lens was removed and replaced with another lens in the same procedure and an anterior vitrectomy was performed and the new replacement lens was placed in the sulcus rather than as per the planned lens.The procedure was extended to approximately 20 to 25 mins.There was no patient harm.The patient is expected to have more post operative astigmatism than planned.

• Brand Name: ACRYSOF IQ TORIC SINGLEPIECE IOL
• Common Device Name: LENS, INTRAOCULAR, TORIC OPTICS
• 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: 18738949
• Report Number: 1119421-2024-00310
• Device Sequence Number: 7242914
• Product Code: MJP
• UDI-Device Identifier: 00380652250467
• UDI-Public: 00380652250467
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/20/2024

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: 05/31/2026
• Device Model Number: SN6AT4
• Device Catalogue Number: SN6AT4.220
• Device Lot Number: 15207440
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/23/2024
• Initial Report FDA Received Date: 02/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/02/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ACRYSOF MULTIPIECE IOL; CENTURION VISION SYSTEM
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown