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 06/20/2019

Event Type  malfunction  

Manufacturer Narrative

Evaluation summary: product history records were reviewed and documentation indicated the product met release criteria.Root cause has not been identified.There has been one other complaint reported in the lot number.Additional information has been requested.The manufacturer internal reference number is: (b)(4).

Event Description

A customer reported during the use of a preloaded intraocular lens (iol) delivery system, the lens was stuck in the injector.There was reported patient contact but no reported patient impact.The procedure was completed using a backup lens.Additional information was requested.

Manufacturer Narrative

The device with the lens was returned loose in a bag.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 almost the fill line and has torn through the trailing optic lens material.The plunger is oriented toward the right side of the device, and slightly retracted toward mid-nozzle.A portion of optic containing the trailing haptic is broken/torn.The optic appears crushed in areas.The trailing haptic is pushed into the optic fold.The leading haptic is tucked into the optic fold.The nozzle was cleaned for further evaluation.The lens was removed during cleaning.Top coat dye stain testing was conducted with unacceptable results.A second testing for top coat was conducted.Top coat dye stain testing results show no top coat present.Product history records were reviewed and the documentation indicated the product met release criteria.A qualified viscoelastic was indicated.The lens was returned advanced/stuck in the device.The optic is torn.The device nozzle was removed and cleaned for further evaluation.Based on the 2 top coat dye stain test results, the nozzle was not top coated.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: 8799103
• MDR Text Key: 151588003
• Report Number: 1119421-2019-01145
• 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: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 11/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2020
• Device Model Number: AU00T0
• Device Lot Number: 12591382
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2019
• Initial Date Manufacturer Received: 07/02/2019
• Initial Date FDA Received: 07/17/2019
• Supplement Dates Manufacturer Received: 11/06/2019
• Supplement Dates FDA Received: 11/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DUOVISC; UNSPECIFIED DUOVISC
• Patient Age: 87 YR