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

Model Number AU00T0

Device Problem Insufficient Information (3190)

Patient Problems Capsular Bag Tear (2639); Vitrectomy (2643)

Event Date 05/08/2018

Event Type  Injury  

Manufacturer Narrative

Evaluation summary: the product was not returned for analysis.The complaint history and product history records could not be reviewed because the reporting facility did not provide a lot number or any identification traceable to the manufacturing documentation.The product investigation could not identify a root cause.Additional information has been requested.The manufacturer internal reference number is: (b)(4).

Event Description

A doctor of ophthalmology reported that during a intraocular lens (iol) implant surgery using a preloaded delivery system, a patient experienced a posterior capsular tear.The surgeon stated the haptic on the lens was open during insertion.The iol was removed and an anterior vitrectomy was performed.The surgeon inserted a three (3) piece lens to complete the case.Additional information has been requested.

Manufacturer Narrative

The device and lens were returned separately.The device was returned loose in a bag inside the carton.The plunger lock and lens stop have been removed from the device.The plunger is oriented correctly.Viscoelastic is observed in the device.No damage was observed to the device.The iol was returned sealed inside a non-company pouch.Viscoelastic was dried on the lens.No damage was observed to the lens.The lens was cleaned with lphse.A dimensional (plan view) inspection was conducted.The lens dimensions are acceptable (plan view) using an approved template.Product history records were reviewed and the documentation indicated the product met release criteria.Viscoelastic was not provided.It is unknown if the qualified product was used.The root cause for the reported complaint could not be determined.The lens and the device were returned separately.It is not possible to determine the position of the haptics while inside the device during delivery.There was no damage observed to the returned lens.The lens dimensions are acceptable (plan view) using an approved template.(b)(4).

• 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: 7531013
• MDR Text Key: 108853024
• Report Number: 1119421-2018-00635
• Device Sequence Number: 1
• Product Code: KYB
• Combination Product (y/n): N
• Reporter Country Code: TU
• PMA/PMN Number: P930014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 08/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2020
• Device Model Number: AU00T0
• Device Lot Number: 12547079
• Other Device ID Number: 00380652358354
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/13/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/08/2017
• 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): Required Intervention
• Patient Age: 81 YR