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

Model Number	SN6AT4
Medical Device Problem Code	Scratched Material (3020)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/07/2022
Type of Reportable Event	Malfunction
Event or Problem Description
A healthcare professional reported following an intraocular lens implant procedure, scratch was observed on the iol inside the eye and decided to explant the iol and use the backup iol.Backup iol was implanted and the surgeon is complaining that the backup iol had on the surface some "rest" of an unknown material.He cleaned the surface, and it looks fine.
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).
Additional Manufacturer Narrative
The lens was returned in a clear liquid inside a syringe.The lens was removed from the syringe for further evaluation.Both haptics are broken (possibly cut) from the optic.The optic was torn/split/cracked and cut into multiple pieces, typical of insertion and removal.The cut optic portions have multiple scratches, deep scrape marks, and scuff marks in the shape of an instrument used to grasp the lens on the anterior and posterior sides of the optic.The indicated video card was not received with the sample.A qualified cartridge and handpiece were indicated.The associated viscoelastic was not provided.It is unknown if a qualified product was used.The reported scratch 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, and the review of manufacturing records, 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.The associated viscoelastic was not provided.It is unknown if a qualified product was used.The instruction for use (ifu) instructs that a 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.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: 15154682
• Report Number: 1119421-2022-01693
• Device Sequence Number: 17451759
• Product Code: MJP
• UDI-Device Identifier: 00380652250498
• UDI-Public: 00380652250498
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/03/2022

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 Model Number: SN6AT4
• Device Catalogue Number: SN6AT4.235
• Device Lot Number: 15356075
• 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: 07/12/2022
• Supplement Date Received by Manufacturer: 09/08/2022
• Initial Report FDA Received Date: 08/03/2022
• Supplement Report FDA Received Date: 10/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/21/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• 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.; UNKNOWN VISCOELASTIC.
• Patient Sex: Unknown