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

Model Number	SN6AT4
Medical Device Problem Code	Ejection Problem (4009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/17/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lens and the qualified company cartridge were returned inside the opened lens carton along with the disassembled lens case.Insufficient viscoelastic was observed in the cartridge.Stress lines were observed at the tip.The cartridge has evidence of being placed into a handpiece.The lens was returned in a small clear bag.Small bits of solution was dried on the lens.No damage was observed to the lens.The lens was cleaned for further evaluation.A dimensional inspection (plan view) was conducted.The lens was within the specification per the approved template.The cartridge was cleaned for further evaluation.Top coat dye stain test was conducted with acceptable results.Product history records were reviewed and documentation indicated the product met release criteria.A non-qualified viscoelastic was indicated.The root cause of the reported complaint may be related to a failure to follow the ifu.A non-qualified viscoelastic was indicated.The ifu instructs that an 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.Company recommends using the qualified company iol delivery system or any other company qualified combination.An inadequate amount of viscoelastic was observed in the cartridge.The ifu also instructs to completely fill the cartridge with ovd(ophthalmic viscosurgical devices) (diagram provided) 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.Top coat dye stain test was conducted with acceptable results.` the manufacturer internal reference number is: (b)(4).
Event or Problem Description
A nurse unit manager reported that the lens was early out of the cartridge at the level of the main incision with patient contact.Additional information was requested.

• 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: 12470755
• Report Number: 1119421-2021-01748
• Device Sequence Number: 11710880
• Product Code: MJP
• UDI-Device Identifier: 00380652250498
• UDI-Public: 00380652250498
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/14/2021

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: 11/19/2025
• Device Model Number: SN6AT4
• Device Catalogue Number: SN6AT4.235
• Device Lot Number: 15116910
• 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: 08/24/2021
• Initial Report FDA Received Date: 09/14/2021
• 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 C; MONARCH IIIC CARTRIDGE; PROVISC OPHTHALMIC VISCOSURGICAL DEVICE; PROVISC OVD