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

Model Number	SA6AT3
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/27/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lens was returned in the lens case.Solution is dried on the lens.A spot is observed near the center of the lens that is damaged.The reflection of this damage gives the appearance of a white area.Small scratches are observed around the damaged area.These scratches may be a result of trying to remove this damaged area thinking it was foreign material.Additional damage is observed to the lens.One haptic is broken in the gusset area (not returned).The optic is split\cut from the edge across the optic.Two deep scratches are observed on the anterior surface of the optic where the optic is split.Two small splits are observed on the edge of the optic.A small crack with missing lens material is observed on the anterior surface of the optic.Marks are observed on the optic in the shape of a surgical instrument used to grasp the lens.Product history records were reviewed and the documentation indicated the product met release criteria.Qualified associated products were indicated.Foreign material was not observed on the lens.A spot is observed near the center of the lens that is damaged.The reflection of this damage gives the appearance of a white area.Small scratches are observed around the damaged area.These scratches may be a result of trying to remove this damaged area thinking it was foreign material.Additional damage is observed to the lens.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, 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.There are no other complaints in this lot.Investigation has been completed based on current information.Based on our current tracking, there are no adverse trends for this reported complaint.No further action warranted at this time.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
An operating room manager reported that during a cataract extraction with intraocular lens (iol) implant surgery, the surgeon implanted a lens and noticed a white spot present on the center of the lens.The surgeon tried to remove the white spot but it was embedded in the iol.The surgeon removed the iol during the same surgery and implanted the same model lens without any issue.No further information is expected.

• Brand Name: ACRYSOF TORIC ASPHERIC UV ABSORBING SINGLEPIECE IOL
• Common Device Name: LENS, INTRAOCULAR, TORIC OPTICS
• Manufacturer (Section D): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• MDR Report Key: 12513038
• Report Number: 1119421-2021-01801
• Device Sequence Number: 3322541
• Product Code: HQL
• UDI-Device Identifier: 00380652335829
• UDI-Public: 00380652335829
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Initial Reporter Country: US
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/22/2021

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: 06/22/2025
• Device Model Number: SA6AT3
• Device Lot Number: 15079390
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/07/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/27/2021
• Initial Report FDA Received Date: 09/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DISCOVISC; MONARCH III IOL INJECTOR; MONARCH III, CARTRIDGE D