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

Model Number AU00T0

Device Problem Material Split, Cut or Torn (4008)

Patient Problem Corneal Edema (1791)

Event Date 07/11/2018

Event Type  Injury  

Manufacturer Narrative

Evaluation summary: the product was not returned for analysis.Product history and batch records were reviewed and documentation indicated the product met release criteria.The product investigation could not identify a root cause.There have been no other complaints reported in the lot number.The manufacturer internal reference number is: (b)(4).

Event Description

A physician reported that during an intraocular lens (iol) implant procedure, the haptic and optic were torn, so we exchanged it.The patient had a prolonged case, and has a lot of corneal edema.Additional information was provided by the physician that the plunger has excessive lateral mobility that captured the iol haptic and iol optic.The sharp edges of plunger applied excessive force on the iol optic and iol haptic and caused it to be damaged.The visualization during the delivery process is not optimal to determine if the iol is going to become entrapped or captured by the plunger.The surgical intervention needed initially was removal of the damaged intraocular lens implant by first removing the iol from the capsular bag, next cutting the iol in 3 pieces, last to remove the iol pieces.The patient has been followed closely by both our facility and the cornea specialist in the community.The patient needed a corneal procedure called descemet's stripping endothelial keratoplasty (dsek) due to the inability for his corneal edema to resolve.As you know corneal edema increases with surgical time and manipulation of the eye.His surgical time was 88 minutes.The surgery was performed by a chief resident from university of (b)(6) with an attending assisting during the complex steps.

Manufacturer Narrative

Product evaluation: the product was not returned.Product history records were reviewed and the documentation indicated the product met release criteria.A non-qualified viscoelastic was indicated.The root cause may be related to a failure to follow the directions for use (dfu).As stated dfu, only qualified viscoelastics must be used in conjunction with the device.All other viscoelastics are not qualified for use.(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: cindy milam ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8176152231
• MDR Report Key: 8095584
• MDR Text Key: 128113679
• Report Number: 1119421-2018-01645
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 01/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2020
• Device Model Number: AU00T0
• Device Lot Number: 12557516
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/03/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/10/2017
• 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
• Treatment: ENDOCOAT
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR