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

Model Number AU00T0

Device Problems Physical Resistance (2578); Malposition of Device (2616)

Patient Problems Eye Injury (1845); Rupture (2208)

Event Date 03/20/2018

Event Type  Injury  

Manufacturer Narrative

A sample device was not returned for analysis.Product history records were reviewed and documentation indicated the product met release criteria.Root cause has not been identified.There are no other complaints in the lot.Additional information was requested and received.(b)(4).

Event Description

A surgeon reported that during an intraocular lens (iol) implant procedure, there was plunger resistance and when additional force was given the lens shot into the eye rupturing the posterior capsule.The lens was implanted into the sulcus outside the capsular bag.Additional information was requested.

Manufacturer Narrative

The product was not returned for evaluation.The provided video was reviewed by qa and r&d.The device preparation was not shown.The device tip comes into view and is inserted into the incision.The lens is rapidly advanced from out of view (mid-nozzle) into the eye.It can be observed that the plunger has overridden the optic.There is a jump as the lens is advanced into the eye.The lens is positioned with an instrument.Slight edge damage is observed where the plunger advanced over the optic.A large piece of loose matter is observed floating onto the anterior optic surface as the eye is filled with solution.The video ends.The lens remains implanted.No intervention shown.Product history records were reviewed and the documentation indicated the product met release criteria.A non-qualified viscoelastic was indicated.Based on review of the provided video the root cause for the reported events appears to be related to a failure to follow the dfu.The lens was advanced from mid-nozzle directly into the eye.The lens was not inspected at the fill line as directed.A plunger override was plainly visible as the lens was advanced.This should have been detected at the inspection step and use of the device discontinued.The observed "jump" into the eye was due to the override and the speed of the delivery.In addition, a non-qualified viscoelastic was indicated.Material properties of non-qualified ovds may contribute to underfill, overfill, misfolding of the haptics, or other inconsistent folding outcomes.As stated in the dfu, only qualified viscoelastics must be used in conjunction with the device.All other viscoelastics are not qualified for use.Lens delivery performance may be negatively affected when using other non-qualified viscoelastics leading to lens delivery issues and /or damage.The use of non-qualified viscoelastics is considered a failure to follow the dfu and is not recommended under any circumstance.(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: 7510519
• MDR Text Key: 108135813
• Report Number: 1119421-2018-00593
• Device Sequence Number: 1
• Product Code: KYB
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P930014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 05/24/2018

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: 07/31/2019
• Device Model Number: AU00T0
• Device Lot Number: 12481865
• Other Device ID Number: 00380652381932
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/18/2018
• Initial Date FDA Received: 05/14/2018
• Supplement Dates Manufacturer Received: 05/17/2018
• Supplement Dates FDA Received: 05/24/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/30/2016
• 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
• Treatment: OPEGAN HI OVD
• Patient Outcome(s): Other
• Patient Age: 93 YR