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

Model Number	SN6AT3
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	04/28/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation summary: the product was returned for analysis.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.Results from the product history record review indicated the product met release criteria.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A nurse reported that there is a dot in the middle of an intraocular lens (iol).Additional information was provided that during an iol implant procedure, after inserting the lens, the dot was noted.The procedure was completed the same day.
Additional Manufacturer Narrative
Additional information provided in h.3., h.6., and h.10.Product evaluation: the lens was returned in the lens case.Viscoelastic is observed on the lens.There are long parallel scrape marks across the center of the posterior and anterior surfaces of the optic.This damage was not observed in the provided photos.This appears to have been caused by an instrument used to grasp the lens during removal.One haptic tip was broken-not returned.The lens was swabbed to remove the viscoelastic.Two very small scratches are observed on the anterior optic surface near the center.Either of these small scratches could be the area observed in the provided photos.Two photos were provided of the lens in the eye.There was a faint mark observed near the center of the optic in both photos.A used qualified cartridge was also returned.Inadequate viscoelastic was observed in the cartridge.No cartridge damage was observed.The cartridge has evidence of placement into a handpiece.The cartridge was cleaned for further evaluation.Top coat dye stain testing was conducted with acceptable results.Iol product history records were reviewed and documentation indicated the product met release criteria.A qualified handpiece and viscoelastic were indicated.The root cause for the reported "dot" could not be determined.Two very small scratches were observed near the center of anterior optic surface.These appeared to correspond to the faint mark observed in the provided photos.The associated cartridge was also evaluated.No damage was observed.Top coat dye stain testing was conducted with acceptable results.All lenses are 100% inspected for cosmetic attributes and the damage exhibited by the returned complaint sample would not have met the manufacturer's release criteria.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
• MDR Report Key: 11854580
• Report Number: 1119421-2021-01066
• Device Sequence Number: 11766379
• Product Code: MJP
• UDI-Device Identifier: 00380652249911
• UDI-Public: 00380652249911
• 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,Followup
• Report Date (Section B): 06/30/2021

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: 10/01/2025
• Device Model Number: SN6AT3
• Device Catalogue Number: SN6AT3.210
• Device Lot Number: 15103281
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2021
• Initial Date Received by Manufacturer: 04/29/2021
• Supplement Date Received by Manufacturer: 06/24/2021
• Initial Report FDA Received Date: 05/20/2021
• Supplement Report FDA Received Date: 06/30/2021
• 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: MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D; MONARCH III IOL DELIVERY SYSTEM, INJECTOR; VISCOAT OPHTHALMIC VISCOSURGICAL DEVICE; MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D; MONARCH III IOL DELIVERY SYSTEM, INJECTOR; VISCOAT OPHTHALMIC VISCOSURGICAL DEVICE