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

Model Number	DFT015
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Capsular Bag Tear (2639)
Date of Event	02/28/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A sample device was not returned for analysis.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.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A non-healthcare professional reported that during a cataract extraction with an intraocular lens (iol) implant procedure, doctor had put a lens into a patient's eye when the lens fragmented and broke into small pieces, then she managed to remove all the pieces.Additional information was received stating posterior capsular rupture after lens insertion (bag blew open with attempted viscoelastic removal via irrigation and aspiration).As per surgeon¿s opinion, product did not contribute to the event.Surgery was completed with 3-piece sulcus lens after the first lens was removed from the eye (removed by cutting it into 3 segments using cutters).Patient's symptoms were resolved.Patient was doing very well with multipiece lens.There was no patient harm.
Additional Manufacturer Narrative
The lens was returned positioned incorrectly in the lens case.Solution was dried on the lens.Both haptics are attached and undamaged.The optic was cut into three sections, typical in appearance to damage created to remove a lens from the eye.Additional split and cracked areas were observed on the optic near the cut lines of damage.Information was provided that indicated the use of a qualified cartridge, handpiece, and viscoelastic.The product investigation could not identify a root cause for the reported complaint of "lens fragmented and broke into small pieces in eye".The lens was returned cut into three portions, typical of damage created to remove a lens from the eye.Additional optic damage was observed.The associated products were qualified for use with the lens.Information was provided that indicated the answer 'no" to the question of "in the surgeon¿s opinion, what product caused or contributed to the event?".No further explanation to that answer was provided.Information was provided that indicated the posterior capsular ruptured after the lens insertion when the surgeon attempted viscoelastic removal via irrigation and aspiration.The surgery was completed with a 3 piece sulcus lens after company lens was removed from the eye (removed by cutting it into 3 segments using mst cutter).The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF IQ VIVITY 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: 16653991
• Report Number: 1119421-2023-00561
• Device Sequence Number: 6521669
• Product Code: POE
• UDI-Device Identifier: 00380652421096
• UDI-Public: 00380652421096
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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,Followup
• Report Date (Section B): 05/09/2023

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 Model Number: DFT015
• Device Lot Number: 15427794
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/03/2023
• Supplement Date Received by Manufacturer: 04/17/2023
• Initial Report FDA Received Date: 03/31/2023
• Supplement Report FDA Received Date: 05/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/14/2022
• 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: DISCOVISC; MONARCH III, CARTRIDGE D; MONARCH III, INJECTOR; MST CUTTERS; STANDARD LENS FORCEPS
• Patient Age: 55 YR
• Patient Sex: Male