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

Model Number TFAT00

Device Problems Use of Device Problem (1670); Patient-Device Incompatibility (2682)

Patient Problems Failure of Implant (1924); Visual Disturbances (2140); Halo (2227)

Event Type  Injury  

Manufacturer Narrative

A sample product 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 are no other complaints in the lot.(b)(4).

Event Description

A facility representative reported that after an intraocular lens (iol) implanted, the patient had halos at night and also glare.Approximately 4.5 months after implantation, the lens was exchanged for another model of lens.Additional information was requested.

Manufacturer Narrative

Three pieces of the explanted lens were returned in the lens case of the replacement lens, placed into the opened lens carton for the replacement lens.Viscoelastic was dried on the lens.Each haptic was cut at the gusset area.Only one large portion of the optic was returned.The optic has multiple areas that are torn and split (cut) across the central optic area.The optic is split on posterior surface and has scratches.A non-qualified viscoelastic was indicated.The root cause could not be determined for the reported complaint of "halos at night; glare (explant)".Three pieces of the explanted lens were returned.Each haptic was cut at the gusset area.Only one large portion of the optic was returned.The optic has multiple areas that are torn and split (cut) across the central optic area.The optic is split on posterior surface and has scratches.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: 11302651
• MDR Text Key: 231015029
• Report Number: 1119421-2021-00268
• 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: other
• Type of Report: Initial,Followup
• Report Date: 03/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: TFAT00
• Device Catalogue Number: TFAT00.235
• Device Lot Number: 12757420
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2021
• Date Manufacturer Received: 03/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: MONARCH III D CARTRIDGE; MONARCH III IOL DELIVERY SYST; OCCUCOAT; MONARCH III D CARTRIDGE; MONARCH III IOL DELIVERY SYST; OCCUCOAT
• Patient Outcome(s): Required Intervention