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

Model Number	DFT315
Medical Device Problem Code	Scratched Material (3020)
Health Effect - Clinical Code	Eye Injury (1845)
Date of Event	07/03/2023
Type of Reportable Event	Malfunction
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.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A physician reported that during an intraocular lens (iol) implant procedure, after the iol implantation, a scratch was found on the iol.The incision was widened to 3 mm so that the iol could be explanted with forceps.A new implantation was performed without complications.Additional information has been received and stated that there was no impairment to the patient.The intraocular pressure (iop) 28mmhg but no action required as on second check pressure was back below 20mmhg on the day of surgery.
Additional Manufacturer Narrative
A photo was provided of the lens inside the eye.The blue markers for positioning are observed having been placed into the eye for positioning.A dark line can be observed horizontally across the central optic zone.This line may be a crack or a scratch.A final determination cannot be made from this photo.A qualified cartridge was used.A non-qualified handpiece and viscoelastic were indicated.Based on our observation of the attached photos, the lens was inside the eye and a dark horizontal line was observed across the optic central zone.This line may be a cracked area or a scratch.It is difficult to make a final determination without evaluation of the physical sample.The root cause may be related to a failure to follow the ifu (instructions for use).A non-handpiece and viscoelastic were used.The ifu instructs: company foldable iols are qualified for use with an company qualified delivery system (handpiece and cartridge) and ophthalmic viscosurgical device (ovd) 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.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: 17424901
• Report Number: 1119421-2023-01352
• Device Sequence Number: 15367920
• Product Code: POE
• UDI-Device Identifier: 00380652421607
• UDI-Public: 00380652421607
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/08/2023

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: DFT315
• Device Lot Number: 15218494
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/10/2023
• Supplement Date Received by Manufacturer: 08/14/2023
• Initial Report FDA Received Date: 07/31/2023
• Supplement Report FDA Received Date: 09/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: ARGON VISC 2,0; ASICO ROYALE; JUNNEMANN FORCEPS; MONARCH III CARTRIDGE D; PROVISC
• Patient Age: 64 YR
• Patient Sex: Male