MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON ACRYSOF IQ VIVITY TORIC EXTENDED VISION IOL; INTRAOCULAR LENS

Model Number	DFT415
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/08/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A sample device was not 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.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A physician reported that, during intraocular lens (iol) implant procedure, the surgeon found that, there is fracture in the optic, for which he decided to explant the lens and implant another with the same characteristics.Additional information was requested.
Additional Manufacturer Narrative
The lens was returned positioned incorrectly in the lens case.Solution was dried on the lens.The optic was cut from edge towards center, typical of insertion and removal.The optic had a crack near the cut damaged area.Complaint history and product history records were reviewed and the documentation indicated the product met release criteria.The file indicated the use of a qualified cartridge and viscoelastic.The handpiece indicated is not qualified for this lens/cartridge combination.The reported optic damage was observed.The root cause for the reported complaint appears to be related to a failure to follow the instructions for use (ifu).The handpiece indicated is not qualified for this lens/cartridge combination.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 intraocular lens (iol) delivery system.Per the device ifu: the qualified cartridge/iol combinations have been validated at an ambient temperature of 18 °c using the driving console setting (1.7 mm/sec, 3 seconds, and 3.0 mm/sec for initial velocity, pause and final velocity respectively).Using a higher velocity and shorter pause at lower temperatures, especially with high diopter lenses, could induce damage to iol and/or iol cartridge, affecting successful iol implantation.There are no other complaints in this lot.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF IQ VIVITY TORIC EXTENDED VISION IOL
• Common Device Name: INTRAOCULAR LENS
• 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: 15649187
• Report Number: 1119421-2022-02241
• Device Sequence Number: 14943735
• Product Code: POE
• UDI-Device Identifier: 00380652422123
• UDI-Public: 00380652422123
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/06/2022

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: 06/12/2026
• Device Model Number: DFT415
• Device Lot Number: 15218458
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/22/2022
• Supplement Date Received by Manufacturer: 11/08/2022
• Initial Report FDA Received Date: 10/21/2022
• Supplement Report FDA Received Date: 12/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/14/2021
• 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: DUOVISC VISCOELASTIC; INFINITI VISION SYSTEM, ACCESSORY, HANDPIECE; INTREPID AUTOSERT IOL; MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D; UNSPECIFIED OPHTHALMIC VISCOSURGICAL DEVICE
• Patient Sex: Female