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

Model Number TFNT00

Device Problem Fracture (1260)

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

Event Date 03/12/2020

Event Type  malfunction  

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.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 Description

A physician reported that during an intraocular lens (iol) implant procedure, when the trailing haptic unfolded, a small microfracture in the optic was revealed.The lens remains implanted in the patient's eye.Additional information was received indicating in the surgeons opinion, the event may have been due to way the lens folded, although it appeared to be folded in the appropriate manner.

Manufacturer Narrative

The manufacturer internal reference number is: (b)(4).

Event Description

Additional information was received by the physician who reported the patient does not notice any halos, but she has very poor range of vision and can't see well at intermediate or at near with the lens.The patent can see clearly at distance and is happy with the quality of her vision with correction at near.She is disappointed with her near rx.The implant is nicely centered on her visual axis with good capsular overlap.The fellow eye has a cataract and she will proceed with a cataract extraction to see if this balances or alleviates some of her difficulty.She has accepted that she may require glasses to achieve her best vision.

Manufacturer Narrative

Product evaluation: the product was not returned.Product history records were reviewed and documentation indicated the product met release criteria.A qualified cartridge and handpiece combination was indicated.A non-qualified viscoelastic was indicated.The lens was not returned to be evaluated.The root cause of the reported lens damage may be related to a failure to follow the dfu.The viscoelastic indicated is not qualified for the lens/cartridge/handpiece combination used.Due to differing material properties, the use of a non-qualified viscoelastic may result in delivery issues and/or damage.During the manufacturing process, each lens is subjected to a 100% assessment of the power and optical resolution in order to determine acceptability per the lens model and diopter.Lens damage induced to the optic area during delivery may affect the visual properties of a lens.Additional information provided in h.3., h.6.And h.10.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF IQ PANOPTIX TRIFOCAL IOL
• Type of Device: LENS, MULTIFOCAL
• Manufacturer (Section D): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• MDR Report Key: 9930208
• MDR Text Key: 187389460
• Report Number: 1119421-2020-00635
• 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: foreign,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 06/29/2020

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: TFNT00
• Device Catalogue Number: TFNT00.190
• Device Lot Number: 12735833
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/12/2020
• Initial Date FDA Received: 04/06/2020
• Supplement Dates Manufacturer Received: 04/09/2020; 06/02/2020
• Supplement Dates FDA Received: 05/05/2020; 06/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: AMVISC PLUS.; MONARCH III D CARTRIDGES, 8065977763, HWV.; MONARCH III IOL DELIVERY SYST, 8065977773, APD.
• Patient Age: 70 YR