MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON ACRYSOF IQ SINGLEPIECE IOL WITH ULTRASERT DELIVERY SYSTEM; LENS, GUIDE, INTRAOCULAR

Model Number AU00T0

Device Problem Entrapment of Device (1212)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/08/2019

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 facility representative reported that during an intraocular lens (iol) implant procedure, the lens became caught in the injector.There was patient contact, but no patient harm.Additional information was requested.

Manufacturer Narrative

The device with the lens was returned in the opened blister tray in the carton.The plunger lock and lens stop have been removed.The plunger is oriented correctly.Viscoelastic is observed in the device.The plunger has advanced the lens to the fill line and has overrode the optic.The lens is slightly rotated toward the right side of the device.The leading haptic is straight with distal tip extended beyond the device.The trailing haptic is misfolded and broken in the gusset area.The distal portion is within the folded optic.The nozzle was cleaned for further evaluation.The lens was removed during cleaning.Top coat dye stain testing was conducted with acceptable results.A qualified viscoelastic was indicated.The lens was advanced/stuck at the fill line.A plunger override was observed.The trailing haptic was misfolded and broken.The root cause cannot be determined.Additional information was provided in d.10., h.3., h.6.And h.10.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF IQ SINGLEPIECE IOL WITH 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: 9392246
• MDR Text Key: 175453959
• Report Number: 1119421-2019-02015
• 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
• Report Date: 01/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2022
• Device Model Number: AU00T0
• Device Lot Number: 12716759
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2019
• Date Manufacturer Received: 01/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNSPECIFIED DUOVISC
• Patient Age: 88 YR