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 Material Deformation (2976)

Patient Problem No Patient Involvement (2645)

Event Date 11/27/2019

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 tip of the lens was deformed.The surgeon did not implant the lens.Additional information has been requested.

Manufacturer Narrative

Additional information provided in d.10., h.3., h.6., and h.10.The device with the lens was returned.The plunger is oriented correctly.Viscoelastic is observed in the device.The plunger is at the trailing optic edge.The lens is advanced to mid-nozzle.The trailing haptic is folded in on the optic.The leading haptic is extended.All product and batch history records are quality reviewed prior to product release.A non-qualified viscoelastic was indicated.No problems are observed with the returned device.The plunger, lens and haptic positions are acceptable.The leading haptic is straight.Straight leading haptics are not a product malfunction.This is an acceptable position per the diagrams provided in the dfu.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: 9676190
• MDR Text Key: 182363619
• Report Number: 1119421-2020-00190
• 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
• Report Date: 03/27/2020

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: 01/31/2021
• Device Model Number: ACU0T0
• Device Lot Number: 12594574
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2020
• Initial Date Manufacturer Received: 01/13/2020
• Initial Date FDA Received: 02/06/2020
• Supplement Dates Manufacturer Received: 03/26/2020
• Supplement Dates FDA Received: 03/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: HEALON