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

Model Number	DFT515
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/18/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product was returned for analysis.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A nurse reported that during an cataract surgery with iol implant surgery, foreign substance was seen after the implantation.The iol was replaced with the other diopter lens.No further information is expected.
Additional Manufacturer Narrative
Two pieces of gauze were returned loose inside the lens carton with the disassembled lens case.A broken haptic was returned adhered by viscoelastic to one piece of gauze.The rest of the lens was returned in pieces adhered by viscoelastic to the second piece of gauze.The lens has been cut across the center of the optic.The two optic pieces were returned adhered to each other.Viscoelastic is dried on both sides of the lens.There also appears to be a small amount of blood on the edges of the lens portions.Gauze fibers are dried in the viscoelastic on both side of the lens.No other foreign material was observed.Product history records were reviewed and documentation indicated the product met release criteria.A qualified cartridge was indicated with a non-qualified handpiece and viscoelastic.The root cause could not be determined for the reported foreign material.A description of the material was not provided.The lens was returned in pieces, which is standard with a lens removal.The lens was returned adhered to gauze with viscoelastic.No other foreign material was observed other than the viscoelastic and gauze.A non-qualified product combination was indicated.The reported foreign material may have been damage.There are no other complaints in this lot.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
Additional information was provided in b.2., b.5.And h.10.Based on information received following submission of the initial report, this event does not meet criteria for reporting as a device malfunction.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information was received it was confirmed that, foreign object was found when the lens was opened, there was no patient contact.
Event or Problem Description
Additional information received and stated that, the hospital was not able to describe the foreign substance, so it was difficult to clarify the foreign substance.It was also stated that facility does not remember the event clearly.It was unknown if there was a patient contact or not.
Additional Manufacturer Narrative
Additional information provided in b.5.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: 12878206
• Report Number: 1119421-2021-02242
• Device Sequence Number: 14561674
• Product Code: POE
• UDI-Device Identifier: 00380652422413
• UDI-Public: 00380652422413
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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: Nurse
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 02/10/2022

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: 12/14/2025
• Device Model Number: DFT515
• Device Lot Number: 15124579
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/02/2021
• Supplement Date Received by Manufacturer: 12/14/2021; 01/18/2022; 01/18/2022
• Initial Report FDA Received Date: 11/26/2021
• Supplement Report FDA Received Date: 01/05/2022; 01/25/2022; 02/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/15/2020
• 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: LG HYA12000.; MILLENNIUM.; MONARCH III CARTRIDGE D.
• Patient Sex: Unknown