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

Model Number	SN6AT7
Medical Device Problem Code	Scratched Material (3020)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/28/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lens was returned positioned incorrectly posterior side up in the lens case.Solution was dried on the lens.Both haptics are bent in the gusset and distal area.The optic was torn/split/cracked and cut into to multiple pieces, typical of insertion and removal.Multiple scratches, smaller cracks, and scrape marks were observed on the anterior and posterior sides of the lens, which may have been interpreted as the reported "indention" complaint.Complaint history and product history records were reviewed and documentation indicated the product met release criteria.The file indicated the use of a qualified cartridge and handpiece.The associated viscoelastic was not provided.It is unknown if a qualified product was used.Upon return, the lens was observed to be placed into the lens case incorrectly resulting in damage.Lens damage was observed that may have been interpreted as the reported "indention" complaint.Other lens damage was observed that may have occurred due to how the lens was positioned in the lens case for return.All lenses are 100% inspected for cosmetic attributes and the damage exhibited by the returned complaint sample would not have met company 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 manufacturer internal reference number is: (b)(4).
Event or Problem Description
A nurse reported during the intraocular lens implantation, it was noticed that the lens had indentations on it.The surgery was competed on the same day.Additional information has been requested and received stating the lens was inserted into the eye and then cut out when the "indention" was seen on the lens.No harm done to the patient, another lens was implanted, and the surgery was successful.

• 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: 15697867
• Report Number: 1119421-2022-02308
• Device Sequence Number: 17981848
• Product Code: MJP
• UDI-Device Identifier: 00380652275767
• UDI-Public: 00380652275767
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 10/31/2022

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: SN6AT7
• Device Catalogue Number: SN6AT7.120
• Device Lot Number: 15329953
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/04/2022
• Initial Report FDA Received Date: 10/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/24/2021
• 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: MONARCH III CARTRIDGE D; MONARCH III INJECTOR
• Patient Age: 62 YR
• Patient Sex: Male