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

Model Number	SN6AT3
Medical Device Problem Codes	Crack (1135); Scratched Material (3020)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/12/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Only the lens case lid was returned.The lens was not returned for evaluation.Product history records were reviewed and documentation indicated the product met release criteria.A qualified lens cartridge was indicated.The handpiece and viscoelastic were not provided.It is unknown if qualified products were used.The product investigation could not identify a root cause for the reported complaint.The product was not returned.The ifu (instructions for use) 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.Company foldable iols are qualified for use with an company qualified delivery system (handpiece and cartridge) and ophthalmic viscosurgical device (ovd) combination.There are no other complaints in this lot.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A facility representative reported that during an intraocular lens (iol) implant procedure, the iol has cracked.The iol was implanted and removed during the initial procedure.Additional information has been requested.
Event or Problem Description
Additional information has been received and stated that, a small linear line seen on implant immediately after implantation of iol.After routine insertion of iol, there was no resistance or unusual detection of any abnormalities during the insertion, the iol was noted to have a linear mark on the posterior side of the iol off the central axis.
Additional Manufacturer Narrative
Additional information provided in a.1., a.2., a.3., b.5., b.6., d.6.A., d.10., e.4., h.3., h.6., and h.10 a qualified associated products were indicated.No determination can be made without physical evaluation of the complaint sample.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: 15355777
• Report Number: 1119421-2022-01901
• Device Sequence Number: 11171699
• Product Code: MJP
• UDI-Device Identifier: 00380652249959
• UDI-Public: 00380652249959
• Combination Product (Y/N): N
• Initial Reporter State: HI
• Initial Reporter Country: US
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/17/2022

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: 06/30/2023
• Device Model Number: SN6AT3
• Device Catalogue Number: SN6AT3.230
• Device Lot Number: 12633082
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/15/2022
• Supplement Date Received by Manufacturer: 09/19/2022
• Initial Report FDA Received Date: 09/05/2022
• Supplement Report FDA Received Date: 10/17/2022
• Date Device Manufactured: 07/10/2018
• 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: MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D; MONARCH III IOL DELIVERY SYSTEM, INJECTOR; VISCOAT
• Patient Age: 76 YR
• Patient Sex: Female