MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON ACRYSOF IQ PANOPTIX UV ABSORBING TRIFOCAL IOL; LENS, MULTIFOCAL

Model Number TFAT00

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/01/2020

Event Type  malfunction  

Manufacturer Narrative

Complaint history and product history records could not be reviewed because the reporting facility did not provide a lot number or any identification traceable to the manufacturing documentation.Root cause has not been identified.Additional information has been requested.The manufacturer internal reference number is: (b)(4).

Event Description

A nurse reported that during multiple intraocular lens (iol) implant procedures in the last 2 weeks with multiple surgeons, a strip of plastic or foreign material was present on the underside of the optic with 2 different lens models.The surgeon can sometimes remove the material with irrigation and aspiration and/or a scraping motion, but seems to leave a scratch or residue behind.It was reported that the finishing from the lumen of the cartridge may be coming off and adhering to the optic.There are 2 medical device reports associated with this event.

Manufacturer Narrative

Product evaluation: the product was not returned for evaluation.Iol product history records were reviewed and documentation indicated the product met release criteria.Photos were provided.Two photos were provided.The incorrect lens model may have been reported.The optic edge and one haptic junction is visible.Rings and toric marks are also observed.An elongated foreign material and/or possibly lens damage is observed.It cannot be determined from the photo if the material is on the anterior or posterior surface of the lens or if it is loose.No determination can be made as to the nature of the material from this photo.An unspecified cartridge was indicated.No other associated products were provided.It cannot be determined if qualified associated products were used.The product investigation could not identify a root cause.The product was not returned for evaluation.No determination can be made without physical evaluation of the complaint sample.The provided photo shows an unknown material and possibly lens damage.No determination can be made as to the nature of the material/damage from this photo.Facility has not responded to follow-up requests.Additional information provided in h.3., h.6.And h.10.The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

A necessary correction was identified.Corrected information has been provided in d2 - part 1.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF IQ PANOPTIX UV ABSORBING TRIFOCAL IOL
• Type of Device: LENS, MULTIFOCAL
• Manufacturer (Section D): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• MDR Report Key: 9871916
• MDR Text Key: 186811281
• Report Number: 1119421-2020-00493
• Device Sequence Number: 1
• Product Code: MFK
• Combination Product (y/n): N
• PMA/PMN Number: P040020
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 06/28/2020

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
• Device Operator: Health Professional
• Device Model Number: TFAT00
• Device Catalogue Number: TFAT00_XXX
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/27/2020
• Initial Date FDA Received: 03/24/2020
• Supplement Dates Manufacturer Received: 03/25/2020; 06/02/2020
• Supplement Dates FDA Received: 04/08/2020; 06/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNK CARTRIDGE.