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

Model Number AU00T0

Device Problems Break (1069); Entrapment of Device (1212)

Patient Problem No Code Available (3191)

Event Date 02/27/2020

Event Type  Injury  

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

An ophthalmologist reported that during a cataract surgery with an intraocular lens (iol) implant, the trailing haptic was trapped and broken inside the injector during the delivery process.The patient was left aphakic and a secondary iol surgery has been scheduled.Additional information has been requested.

Manufacturer Narrative

Additional information has been provided in d.10., h.3., h.6.And h.10.Evaluation summary: the device with the broken haptic was returned in the opened blister tray inside the opened carton.The plunger was oriented correctly.Viscoelastic was observed in the device.The plunger has been retracted to mid-nozzle.The reported broken haptic was observed.The haptic was located ahead of the plunger in the nozzle.The distal portion was facing the end of the nozzle.The remainder of the lens was not returned.Product history records were reviewed and the documentation indicated the product met release criteria.A qualified viscoelastic was indicated.The root cause cannot be determined for the reported event of "haptic trapped and broken inside the injector".A broken haptic was observed in front of the plunger with the distal portion oriented toward the nozzle tip.The plunger was retracted.The plunger position in relation to the broken haptic during advancement cannot be determined.The haptic position may indicate the plunger was not fully advanced.If the plunger is not fully advanced the trailing haptic may not release properly from the device.A qualified viscoelastic was indicated.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: 9903361
• MDR Text Key: 186607425
• Report Number: 1119421-2020-00560
• 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: 01/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2022
• Device Model Number: AU00T0
• Device Lot Number: 12746769
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2020
• Date Manufacturer Received: 12/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNSPECIFIED DISCOVISC OVD
• Patient Outcome(s): Other