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

Model Number	DFT015
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Codes	Eye Injury (1845); Insufficient Information (4580)
Date of Event	02/18/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A health care professional reported that there was lens split noted.Additional information has been requested; however, further information has not been received.
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
Additional information was requested and received stating lens carefully inserted into introducer taking care not to touch optic.The wound noted to be slightly tight so rather than forcing nozzle into eye, wound slightly enlarged then nozzle inserted with ease.After iol opened in bag, a small split was noted in the center of the lens.The decision made to do lens exchange.Second spare company lens used and injected with ease beneath initial iol into bag and secured.Split lens was then cut with scissor and removed in two halves carefully from the eye.There was no harm to patient, post operation vision 6/6 at 3 weeks with 0.25 refraction (aim was plano).Patient delighted and due for second eye lens operation.
Additional Manufacturer Narrative
The product was not returned.Product history records were reviewed and the documentation indicated the product met release criteria.The file indicates the use of an unspecified cartridge and an unspecified handpiece.The file also indicated the use of a non-qualified viscoelastic.The root cause for the reported complaint may be related to a failure to follow the instruction for use (ifu).The viscoelastic indicated is not qualified for the lens/monarch combination used.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 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: 16642264
• Report Number: 1119421-2023-00559
• Device Sequence Number: 6097740
• Product Code: POE
• UDI-Device Identifier: 00380652421201
• UDI-Public: 00380652421201
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 05/11/2023

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: 07/25/2026
• Device Model Number: DFT015
• Device Lot Number: 15240176
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/03/2023
• Supplement Date Received by Manufacturer: 04/17/2023
• Initial Report FDA Received Date: 03/30/2023
• Supplement Report FDA Received Date: 05/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/27/2021
• 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: UNSPECIFIED CARTRIDGE.; UNSPECIFIED INJECTOR.; VANNA SCISSOR.; VISCOELASTIC BIOHYLUR.
• Patient Sex: Unknown