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	09/26/2022
Type of Reportable Event	Malfunction
Event or Problem Description
A non healthcare professional reported that there was a fiber in the implanted lens.Additional information received stating that there was no patient harm.
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.(b)(4).
Additional Manufacturer Narrative
The lens and reported fiber were not returned for evaluation.One opened 10-count carton for company cartridge was returned.One used company cartridge was in the carton sealed in a non-company pouch.Seven unopened company cartridges were returned in the carton lot.The returned used company cartridge was microscopically examined.Inadequate viscoelastic was observed in the cartridge.The tip was damaged on the left side (internal).The cartridge had evidence of placement into a handpiece.The used company cartridge was cleaned for further evaluation.Top coat dye stain testing was conducted with acceptable results for the presence of top coat.Internal damage was observed with disruption in the coating on the bottom and left side of the tip.One of the returned unopened company cartridges was opened and microscopically examined with no damage observed.No particulate was observed inside the cartridge lumen.The company cartridge was functionally tested per the ifu(instruction for use).No lens or cartridge damage was observed after the lens delivery.No foreign material was observed.The company cartridge was cleaned for further evaluation.Top coat dye stain testing was conducted with acceptable results.Qualified associated products were indicated.The root cause for the reported fiber could not be determined.The lens and fiber were not returned for evaluation.Although it was stated the cartridge was filled with viscoelastic, the returned used cartridge did not appear to have been properly filled.Based on review of the returned used cartridge, the reported fiber may have been internal coating material from the damaged company cartridge tip.One of the returned unopened company cartridges was functional and dye stain tested.No lens or cartridge damage or foreign material was observed after the lens delivery.Top coat day stain testing was conducted with acceptable results.The ifu instructs to completely fill the cartridge with ovd(ophthalmic viscosurgical device ) immediately prior to loading and delivery of the lens.Do not attempt to load the lens without adequate ovd in the device.Not adequately filling the device with viscoelastic will result in inadequate coverage of lens and the lens fold path with ovd, which may result in damage.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: 15706562
• Report Number: 1119421-2022-02323
• Device Sequence Number: 6630600
• Product Code: MJP
• UDI-Device Identifier: 00380652249829
• UDI-Public: 00380652249829
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/05/2022

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: 04/06/2026
• Device Model Number: SN6AT3
• Device Catalogue Number: SN6AT3.165
• Device Lot Number: 15182997
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/07/2022
• Supplement Date Received by Manufacturer: 11/11/2022
• Initial Report FDA Received Date: 11/01/2022
• Supplement Report FDA Received Date: 12/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/08/2021
• 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: CUSTOM-PAK; MONARCH III IOL CARTRIDGE D; MONARCH III IOL INJECTOR; PROVISC
• Patient Age: 63 YR
• Patient Sex: Female