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

Model Number	SN6AT4
Medical Device Problem Codes	Difficult to Fold, Unfold or Collapse (1254); Defective Device (2588)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/09/2022
Type of Reportable Event	Malfunction
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 have been no other complaints reported in the lot number.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A healthcare professional reported that during implantation of an intraocular lens (iol) the lens was found to be too stiff to implant, tried to insert the lens onto lens cartridge, the lens did not fold properly.When inserted into the eye, the surgeon found the lens was defective.Then lens was removed and replaced with another lens of a different batch number.Additional information was requested and received.
Additional Manufacturer Narrative
The lens was returned for evaluation.Solution is dried on the lens.One haptic is pointing down into a drain hole in the lens case.Multiple split cracks are observed along the edge of the optic going towards the center of the optic.Deep scratch marks are observed on both the anterior and posterior surfaces of the optic.A large piece is broken off of the edge of the lens in the shape of a post in the lens case which could have been cause by replacing the lens incorrectly in the lens case for return.A dimensional inspection could not be conducted due to extensive damage.A fold inspection could not be conducted due to extensive damage.All product and batch history records are quality reviewed prior to product release.Lens damage was observed.All lenses are 100% inspected for cosmetic attributes and the damage exhibited by the returned complaint sample would not have met company¿s release criteria.Based on our observation, it can be reasonably concluded that the damage is not manufacturing related.Due to the presence of surgical solution and the condition of the returned sample, the damage is most likely related to customer handling.We are unable to verify the reported complaint of a folding issue.The manufacturer internal reference number is: (b)(4).

• 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: 13709314
• Report Number: 1119421-2022-00433
• Device Sequence Number: 12095354
• Product Code: MJP
• UDI-Device Identifier: 00380652250405
• UDI-Public: 00380652250405
• Combination Product (Y/N): N
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/29/2022

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: 04/27/2026
• Device Model Number: SN6AT4
• Device Catalogue Number: SN6AT4.190
• Device Lot Number: 15191872
• 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: 02/14/2022
• Supplement Date Received by Manufacturer: 04/05/2022
• Initial Report FDA Received Date: 03/09/2022
• Supplement Report FDA Received Date: 04/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/29/2021
• 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: 72 YR
• Patient Sex: Female