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

Model Number AU00T0

Device Problems Partial Blockage (1065); Entrapment of Device (1212); Material Rupture (1546)

Patient Problem Rupture (2208)

Event Date 04/12/2017

Event Type  Injury  

Manufacturer Narrative

The device was received by a company representative and is in transit to the manufacturing site for investigation.Product history records were reviewed and documentation indicated the product met release criteria.Investigation including root cause analysis will be completed.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.There is one other complaint in the reported lot.Additional information was requested and received.The manufacturer internal reference number is: (b)(4).

Event Description

A pharmacist reported that a lens did not unfold and was blocked in the injector during an intraocular lens (iol) implant procedure.The tip was in the capsular bag and the lens got stuck.The capsular bag was ruptured and device with the lens was removed.Another iol was implanted.Additional information has been requested and received.

Manufacturer Narrative

The device with the iol was returned.The plunger lock and lens stop have been removed.Viscoelastic is dried in the device.The plunger is oriented correctly.The plunger has been retracted into the loading area.The lens is located just inside the nozzle entry area.The leading and trailing haptics are in acceptable positions.Product history records were reviewed and the documentation indicated the product met release criteria.Viscoelastic used was not provided.It is unknown if a qualified viscoelastic product was used in the device.The root cause could not be determined for 'blocked in injector, capsular rupture".The device was returned with lens advanced to just inside the nozzle entry area.The plunger was retracted into the loading area.It is unknown if a qualified viscoelastic was used.Material properties of non-qualified ovds may contribute to underfill, overfill, misfolding of the haptics, or other inconsistent folding outcomes.The root cause of the capsular rupture cannot be determined.Lens delivery and removal from the eye cannot be confirmed based on the position of the iol in the device when returned.It is possible that the lens has been replaced into the device for return.(b)(4).

• Brand Name: ACRYSOF IQ SINGLEPIECE IOL W/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: nadia bailey ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8176152230
• MDR Report Key: 6719823
• MDR Text Key: 80244618
• Report Number: 1119421-2017-00903
• Device Sequence Number: 1
• Product Code: KYB
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P930014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 08/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2019
• Device Model Number: AU00T0
• Device Catalogue Number: AU00T0.220
• Device Lot Number: 12498739
• Other Device ID Number: 00380652358316
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/25/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/13/2016
• 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: 78 YR