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

Model Number AU00T0

Device Problem Scratched Material (3020)

Patient Problem No Information (3190)

Event Date 06/12/2018

Event Type  malfunction  

Manufacturer Narrative

The device was not returned for evaluation.Product history records were reviewed and documentation indicated the product met release criteria.Root cause has not been identified.There have been no other complaints reported in the lot number.Additional information has been requested.(b)(4).

Event Description

A customer reported there was a scratch on an intraocular lens (iol) around the trailing haptic/optic in a preloaded delivery system.The scratch was confirmed after implant into the patient's eye.The lens remains implanted.Additional information received reports the physician noted the damage was on the lens from the beginning and was not caused by the delivery system.

Manufacturer Narrative

The product was not returned.The provided dvd was reviewed.The device preparation and initial lens advancement are not shown.The device comes into view with the lens advanced to the fill line.Both haptics are tucked.The lens is delivered without issue.A semi-circular very fine "line" is observed on the optic.This "line" is on the leading optic side.This appears to be on the posterior surface although it can't be definitively determined from review of the dvd.Unable to determine if this is a scratch; a line/crease or a molding artifact.This does not appear to be delivery related damage.R&d reviewed the photos and indicated does the line does not appear to be delivery related.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 product was not returned for evaluation.The lens remains implanted.A dvd was provided.The device preparation and initial advancement were not shown.The lens is delivered without issue.A semi-circular very fine "line" is observed on the optic.This "line" is on the leading optic side.This appears to be on the posterior surface although it can't be definitively determined from review of the dvd.Unable to determine if this is a scratch or line/crease.Unable to determine if this is a scratch; a line/crease or a molding artifact.This does not appear to be delivery related damage.No further determination can be made with out physical evaluation of the sample.(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: 7634280
• MDR Text Key: 112445118
• Report Number: 1119421-2018-00807
• 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: 07/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2019
• Device Model Number: AU00T0
• Device Lot Number: 12487751
• Other Device ID Number: 00380652381895
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/18/2018
• 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
• Patient Outcome(s): Other