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

Model Number	DAT515
Medical Device Problem Codes	Break (1069); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/31/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complaint history and product history records were reviewed and documentation indicated the product met release criteria.There were no other complaints reported in the lot number.Root cause has not been identified.Additional information was requested.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A nurse reported that during a cataract surgery with an intraocular lens (iol) implantation, the lens emerged from the injector in pieces.The trailing haptic was in pieces and the optic was shattered at the insertion points of the shorn haptic.The lens material was brittle and shard-like.The iol was replaced in the same procedure with no reported harm to the patient.Additional information has been requested.
Additional Manufacturer Narrative
The lens was returned for evaluation.Solution is dried on the lens.Seven pieces of the lens were returned.One piece of the distal area of a haptic is broken and returned.One other piece is the gusset area part of the haptic.The optic is broken into multiple pieces.Product history records were reviewed and the documentation indicated the product met release criteria.Qualified associated products were indicated.The reported lens damage was observed.All lenses are 100% inspected for cosmetic attributes and the damage exhibited by the returned complaint sample would not have met companies' release criteria.Based on our observation, and the review of manufacturing records, it can be reasonably concluded that the damage is not manufacturing related.Due to the presence of surgical solution and the condition of the returned sample, the damage is most likely related to customer handling.Upon inspection of the lens there we no abnormalities noted with the lens material.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF IQ VIVITY TORIC EXTENDED VISION UV ABSORBING IOL
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• MDR Report Key: 11752204
• Report Number: 1119421-2021-00930
• Device Sequence Number: 19868030
• Product Code: POE
• UDI-Device Identifier: 00380652428781
• UDI-Public: 380652428781
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/13/2021

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: 03/08/2025
• Device Model Number: DAT515
• Device Lot Number: 15057724
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/06/2021
• Initial Date Received by Manufacturer: 04/06/2021
• Supplement Date Received by Manufacturer: 05/10/2021
• Initial Report FDA Received Date: 04/30/2021
• Supplement Report FDA Received Date: 05/13/2021
• 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: MONARCH III IOL CARTRIDGE D; MONARCH III IOL INJECTOR; PROVISC; MONARCH III IOL CARTRIDGE D; MONARCH III IOL INJECTOR; PROVISC
• Patient Age: 63 YR