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

Model Number AU00T0

Device Problems Crack (1135); Failure to Fold (1255)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/22/2019

Event Type  malfunction  

Manufacturer Narrative

Evaluation summary: the product was not returned for analysis.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.(b)(4).

Event Description

A surgical technician reported that an intraocular lens (iol) was prepared with viscoelastic and was left until the doctor was ready.During the cataract extraction with iol implantation, when the lens was handed to the doctor, one of the legs crawled out and was not folded like it normally is.The doctor started to put the lens into the eye, then heard a crack.He then unfolded the lens and saw a crack on it.The viscoelastic was left in the lens for about 5 minutes.Additional information was requested and received.

Manufacturer Narrative

Product evaluation: the device with the lens was returned loose in the carton.The plunger lock and lens stop have been removed.The plunger is oriented correctly.There is only a small amount of viscoelastic observed in the device.The report indicated the lens was delivered and unfolded by the surgeon and a crack was noticed.The lens and plunger positions upon return are not applicable as the plunger has been retracted and the lens replaced into the loading area.The leading haptic is misfolded under the optic and is torn/split at the haptic/optic junction.The optic edge is torn in two places.The nozzle was cleaned for further evaluation.The lens was removed during cleaning.Top coat dye stain testing was conducted with acceptable results.Product history records were reviewed and the documentation indicated the product met release criteria.A qualified viscoelastic was used in the device.The device was returned with the lens replaced in the loading area.Torn optic and broken haptic damage was observed.The root cause of the complaint may be related to a failure to follow the dfu.The customer stated the device was prepared and sat for 5 minutes before the surgeon attempted to use.In addition, an inadequate amount of viscoelastic was observed in the device.If inadequate viscoelastic is placed in the device this will cause inadequate coverage of the lens fold path which may cause the lens to advance incorrectly or become ¿stuck¿ in the device.It is unknown if a qualified viscoelastic was used.Top coat dye stain testing was conducted with acceptable results.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: 8351221
• MDR Text Key: 136728251
• Report Number: 1119421-2019-00181
• 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: health professional
• Type of Report: Initial,Followup
• Report Date: 05/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2021
• Device Model Number: AU00T0
• Device Lot Number: 12636901
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/14/2019
• Date Manufacturer Received: 04/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PROVISC
• Patient Age: 73 YR