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

Model Number AU00T0

Device Problem Failure to Advance (2524)

Patient Problems Eye Injury (1845); Device Embedded In Tissue or Plaque (3165)

Event Date 10/23/2019

Event Type  Injury  

Manufacturer Narrative

A sample product was not returned for analysis. Complaint history and 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. (b)(4).

Event Description

A surgeon reported that during an intraocular lens (iol) implant procedure, the trailing haptic stuck inside the loading device, while the rest of the lens was inserted into the eye and then removed. The patient was left aphakic with a plan to implant a lens the following week. Additional information was requested.

• Brand Name: ACRYSOF IQ SINGLEPIECE IOL WITH ULTRASERT DELIVERY SYSTEM
• Type of Device: LENS, GUIDE, INTRAOCULAR
• Manufacturer (Section D): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• Manufacturer (Section G): ALCON RESEARCH, LLC - 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: 9321870
• Report Number: 1119421-2019-01915
• Device Sequence Number: 1
• Product Code: KYB
• Combination Product (y/n): N
• Reporter Country Code: MY
• PMA/PMN Number: P930014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional

Reporter Occupation

• Type of Report: Initial
• Report Date: 11/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 02/28/2021
• Device Model Number: AU00T0
• Device Lot Number: 12603202
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 10/23/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/20/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Treatment(s): DISCOVISC OVD
• Patient Outcome(s): Other; Disability