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

Model Number AU00T0

Device Problems Loose or Intermittent Connection (1371); Activation, Positioning or Separation Problem (2906)

Patient Problem Failure of Implant (1924)

Event Date 09/16/2019

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 is one other complaint in the lot.The manufacturer internal reference number is: (b)(4).

Event Description

A facility representative reported that during an intraocular lens (iol) insertion into an eye, the lens was injected improperly, which loosened the bag causing the support for the lens to be lost.The lens was removed.Additional information was requested.

Manufacturer Narrative

The manufacturer internal reference number is: (b)(4).

Event Description

A nurse reported that severe zonulopathy due to pseudoexfoliation and a dense brunescent cataract contributed to the event.An anterior chamber iol was implanted back into the patient's eye during the initial surgery.

• 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
• MDR Report Key: 9188853
• MDR Text Key: 162603341
• Report Number: 1119421-2019-01689
• Device Sequence Number: 1
• Product Code: KYB
• Combination Product (y/n): N
• PMA/PMN Number: P930014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Type of Report: Initial,Followup
• Report Date: 12/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2022
• Device Model Number: AU00T0
• Device Lot Number: 12697126
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DUOVISC VISCOELASTIC; PROVISC OVD
• Patient Outcome(s): Other
• Patient Age: 74 YR