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 Problems Blurred Vision (2137); Visual Disturbances (2140)

Event Type  Injury  

Manufacturer Narrative

Complaint history and product history records were reviewed and documentation indicated the product met release criteria.There have been no other complaints reported in the lot number.Root cause has not been identified.Additional information was requested.The manufacturer internal reference number is: (b)(4).

Event Description

A facility representative reported that an intraocular lens (iol) was exchanged as patient was not happy with the vision and was unable to tolerate the lens.Patient also experienced blurry vision and rings.Additional information was requested.

Manufacturer Narrative

Additional information provided in a.3, d.10, h.3, h.6 and h.10.The lens was returned inside a small plastic specimen jar with a screw top lid.The lens was returned submerged in clear solution.The optic was cut horizontally from edge to edge.Only one half was returned.No damage was observed to this half.The other half of the lens could not be evaluated because it was not returned.Product history records were reviewed documentation indicated the product met release criteria.Associated product information has not been provided.It is unknown if qualified associated products were used with this lens.The root cause cannot be determined for the reported event.Only one half of the explanted lens was returned.Each lens is subjected to a 100% assessment of the power and optical resolution during the manufacturing process in order to determine acceptability per the lens model and diopter.Information provided by initial reporter indicated that the clinical reason for explant was due to ¿unable to tolerate multifocal lens, blurred vision with multifocal lens¿.The replacement lens model and diopter information has not been provided.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: 10907499
• MDR Text Key: 218501469
• Report Number: 1119421-2020-01781
• 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,other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 01/04/2021

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: TFAT40.140
• Device Lot Number: 12758624
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2020
• Initial Date Manufacturer Received: 11/04/2020
• Initial Date FDA Received: 11/26/2020
• Supplement Dates Manufacturer Received: 12/07/2020
• Supplement Dates FDA Received: 01/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention