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

Model Number AU00T0

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Capsular Bag Tear (2639)

Event Date 05/23/2018

Event Type  Injury  

Manufacturer Narrative

The device with the lens was returned loose in a biohazard bag in the carton.The plunger lock and lens stop have been removed.Inadequate viscoelastic is observed in the device.The plunger is oriented correctly.The plunger has been retracted into the barrel prior to the entry area of the loading area.The lens is still in the loading area and has been slightly advanced.No damage is observed to the lens.No device tip damage was observed.The plunger was removed and evaluated.No damage was observed to the plunger tip.Product history records were reviewed and the documentation indicated the product met release criteria.Viscoelastic was not provided.The root cause for the reported complaint of "posterior capsular tear" cannot be determined.No damage was found to the lens, plunger, or device.The sample evaluation may indicate a plunger override occurred.The lens was in the loading area and the plunger was retracted prior to the lens loading entry area.An inadequate amount of viscoelastic was observed in the device.The dfu instructs: fill the device until viscoelastic can be observed flowing to the line on the nozzle tip.This will require approximately 0.2 ml of viscoelastic.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 allowing the plunger to override the lens.It is unknown if a qualified viscoelastic was used.There are no other complaints in the lot.Additional information was requested and received.(b)(4).

Event Description

An operating room manager reported that during an intraocular lens (iol) implant procedure, the lens shot into the eye causing a posterior capsular tear localized at the nasal periphery without vitreous leak.Another lens was used to complete the case.In follow up, the reporter indicated that the patient is doing well.

• Brand Name: ACRYSOF IQ SINGLEPIECE IOL WITH ULTRASERT DELIVERY SYSTEM
• Type of Device: LENS, GUIDE, INTRAOCULAR
• Manufacturer (Section D): ALCON RESEARCH, LTD. - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• Manufacturer (Section G): ALCON RESEARCH, LTD. - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• Manufacturer Contact: bryan blake ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8176152230
• MDR Report Key: 7639453
• MDR Text Key: 112385357
• Report Number: 1119421-2018-00821
• Device Sequence Number: 1
• Product Code: KYB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P930014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 06/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2020
• Device Model Number: AU00T0
• Device Lot Number: 12567377
• Other Device ID Number: 00380652394550
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/31/2018
• Initial Date FDA Received: 06/26/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/07/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 62 YR