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

Model Number AU00T0

Device Problem Use of Device Problem (1670)

Patient Problem Capsular Bag Tear (2639)

Event Date 11/16/2017

Event Type  Injury  

Manufacturer Narrative

Product evaluation: the product was not returned for analysis.Complaint history and product history records were reviewed and documentation indicated the product met release criteria.There have been no other complaints reported in the lot number.A root cause has not been identified.(b)(4).

Event Description

A facility representative reported that during a cataract removal with intraocular lens (iol) implant procedure, a folding issue led to a capsular bag rupture, as the iol left the injector too quickly (quick release).The iol was cut to be removed from the patient's eye, and a multipiece iol was placed in the sulcus instead.It was noted that the injector and iol involved are not available for return.Additional information has been requested.

Manufacturer Narrative

Product evaluation: viscoelastic was not provided; it is unknown if a qualified product was used.The product investigation could not identify a root cause.Material properties of non-qualified ovds (ophthalmic viscosurgical devices) may contribute to underfill, overfill, misfolding of the haptics, or other inconsistent folding outcomes.(b)(4).

Event Description

Additional information was received, indicating that after injection of the implant, the surgeon noticed that the implant was folded in the eye.

Manufacturer Narrative

(b)(4).

Event Description

Additional information was received, indicating that after injection of the implant, the surgeon noticed that the implant was "crumpled" in the eye.In a returned questionnaire, the implanting physician confirmed that sudden release of the iol from the preloaded cartridge led the central posterior capsule tear.It was also reported that anterior vitrectomy was performed as vitreous presented.Implantation of a posterior chamber lens into the sulcus was also performed after removal of the first lens through an enlarged incision.The incision was then sutured with two stitches.The surgeon confirmed that although the patient had strong myopia, there was no capsular damage noted after the phaco step and before implantation of the lens.There has been no sign of retinal detachment.

• 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: nadia bailey ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8176152230
• MDR Report Key: 7141401
• MDR Text Key: 95587528
• Report Number: 1119421-2017-01427
• 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: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2019
• Device Model Number: AU00T0
• Device Lot Number: 12438073
• Other Device ID Number: 00380652358026
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/14/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/31/2016
• 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: 64 YR