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

Model Number TFAT40

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Therapeutic Effects, Unexpected (2099)

Event Date 10/05/2020

Event Type  Injury  

Manufacturer Narrative

Evaluation summary: the product was not returned for analysis.The product history and batch records were reviewed and documentation indicated the product met release criteria.The product investigation could not identify a root cause.There has been one other complaint reported in the lot number.The manufacturer internal reference number is: (b)(4).

Event Description

A physician reported that following an intraocular lens (iol) implant procedure, despite a perfect looking outcome and repeat corneal topography confirms that the lens is the right power and in the right axis, the patient is unable to be refracted better than 20/40 for distance and j5 near.According to the physician, " i have no clear explanation other than the design of the lens doesn't work well with the make up of her eye/retina." additional information was provided indicating that the iol was exchanged for a different iol model approximately 6 weeks following the initial implantation.

Manufacturer Narrative

Evaluation summary: potential associated product provided.These are unrelated to the reported visual issue.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF IQ PANOPTIX TORIC 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: 10915119
• MDR Text Key: 218633256
• Report Number: 1119421-2020-01782
• 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: company representative,health
• Type of Report: Initial,Followup
• Report Date: 02/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: TFAT40
• Device Catalogue Number: TFAT40.190
• Device Lot Number: 15021609
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/10/2020
• Initial Date FDA Received: 11/27/2020
• Supplement Dates Manufacturer Received: 01/13/2021
• Supplement Dates FDA Received: 02/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNSPECIFIED DUOVISC VISCOELASTIC SYSTEM; UNSPECIFIED MONARCH CARTRIDGES, HWV; UNSPECIFIED MONARCH IOL DELIVERY SYST, APD
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR