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

Model Number ACU0T0

Device Problems Material Deformation (2976); Physical Resistance/Sticking (4012)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/02/2019

Event Type  malfunction  

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.The manufacturer internal reference number is: (b)(4).

Event Description

A materials manager reported that during an intraocular lens (iol) implant procedure, the lens folded and became stuck.There was patient contact, but no patient harm.Procedure was completed with another lens instead.Additional information was requested.

Manufacturer Narrative

Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

Only the device was returned loose in the carton.The plunger lock and lens stop have been removed.The plunger is oriented correctly.Viscoelastic was observed in the device.The plunger was retracted to mid nozzle.The lens was not in the device.The nozzle was cleaned for further evaluation.Top coat dye stain testing was conducted with acceptable results.A qualified viscoelastic was used.The root cause cannot be determined for the complaint of "lens folded and would not advance".The position of the lens inside the device during advancement is unknown.The lens was not inside the device upon return.No damage was observed to the device.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: 8546809
• MDR Text Key: 143039335
• Report Number: 1119421-2019-00533
• 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: other
• Type of Report: Initial,Followup,Followup
• Report Date: 07/08/2019

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: 12597904
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2019
• Initial Date Manufacturer Received: 04/02/2019
• Initial Date FDA Received: 04/24/2019
• Supplement Dates Manufacturer Received: 05/20/2019; 07/01/2019
• Supplement Dates FDA Received: 06/09/2019; 07/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PROVISC
• Patient Age: 69 YR