MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON ACRYSOF IQ ASPHERIC UV ABSORBING IOLWITH ULTRASERT DELIVERY SYSTEM; LENS, GUIDE, INTRAOCULAR

Model Number ACU0T0

Device Problem Use of Device Problem (1670)

Patient Problems Failure of Implant (1924); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  malfunction  

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 have been no other complaints reported in the lot number.The manufacturer internal reference number is: (b)(4).

Event Description

A health professional reported that during an intraocular lens (iol) implant surgery, the plunger went over the lens.The device was exchanged to complete the case.There was patient impact.

Event Description

Originally reported that there was patient impact which was not correct.There was no patient impact.

Manufacturer Narrative

Corrected information provided in b.5.The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

The device with the lens was returned.The plunger lock and lens stop have been removed.The plunger is oriented correctly.Viscoelastic was dried in the device.The plunger has been advanced to mid-nozzle.The plunger has underrode the lens.The lens is located within the lens loading area.The trailing haptic was positioned on top of the plunger.The leading haptic was positioned on the plunger and extended to the right side of the device.All product and batch history records are quality reviewed prior to product release.Viscoelastic was not provided.It is unknown if the qualified product was used.The root cause could not be determined for the reported issue.The used device was evaluated.A plunger underride was observed.The lens was still within the lens loading area.The plunger underride was most likely interpreted as the reported complaint.It is unknown if a qualified viscoelastic was used.Material properties of non-qualified ovds may contribute to underfill, overfill, misfolding of the haptics, or other inconsistent folding outcomes.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF IQ ASPHERIC UV ABSORBING IOLWITH ULTRASERT DELIVERY SYSTEM
• Type of Device: LENS, GUIDE, INTRAOCULAR
• Manufacturer (Section D): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• MDR Report Key: 10677586
• MDR Text Key: 213169306
• Report Number: 1119421-2020-01461
• Device Sequence Number: 1
• Product Code: KYB
• Combination Product (y/n): N
• PMA/PMN Number: P930014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 12/18/2020

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 Expiration Date: 01/12/2023
• Device Model Number: ACU0T0
• Device Lot Number: 15004734
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2020
• Initial Date Manufacturer Received: 10/13/2020
• Initial Date FDA Received: 10/14/2020
• Supplement Dates Manufacturer Received: 10/14/2020; 12/16/2020
• Supplement Dates FDA Received: 10/16/2020; 12/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1