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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/05/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complaint history and 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.Additional information has been requested.The manufacturer internal reference number is (b)(4).
Event or Problem Description
A non-healthcare professional reported lens broken noticed after insertion and was retrieved from the eye during initial procedure.The procedure was completed with another lens.There were no consequence to the patient.Additional information was requested.
Additional Manufacturer Narrative
The product was returned inside a sealed non-company peel pouch.The lens was returned outside the lens case, adhered by solution to the lens case base.One haptic/optic junction area is broken (possibly cut) from the lens (returned).The optic was torn/split/cracked and cut into multiple pieces.Typical of insertion and removal (returned).The file indicated, the use of a qualified cartridge.The root cause may be related to failure to follow the dfu.The file indicated, the use of a viscoelastic, that is not qualified for the lens/cartridge combination used.Due to varying material properties, the use of non-qualified viscoelastic may result in lens delivery difficulties or product damage.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
• MDR Report Key: 11885956
• Report Number: 1119421-2021-01107
• Device Sequence Number: 1388027
• Product Code: POE
• UDI-Device Identifier: 00380652421300
• UDI-Public: 00380652421300
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/21/2021

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: 01/03/2026
• Device Model Number: DFT015
• Device Lot Number: 15124360
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/23/2021
• Initial Date Received by Manufacturer: 05/06/2021
• Supplement Date Received by Manufacturer: 06/28/2021
• Initial Report FDA Received Date: 05/26/2021
• Supplement Report FDA Received Date: 07/21/2021
• 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: MEGA BIO; MONARCH III CARTRIDGE D; MEGA BIO; MONARCH III CARTRIDGE D