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

Model Number AU00T0

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Rupture (2208)

Event Date 11/14/2019

Event Type  Injury  

Manufacturer Narrative

The 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 have been no other complaints in this lot.(b)(4).

Event Description

A customer reported a ruptured capsule following the implant of a preloaded intraocular lens (iol).The lens was removed, a vitrectomy was performed and a three piece iol was placed.The patient issues are reported as resolved.

Manufacturer Narrative

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

Event Description

Additional information received; the reporter indicated that the lens was not the cause of the ruptured capsule.

Manufacturer Narrative

Additional information provided in h.3, h.6 and h.10.A non-qualified viscoelastic was indicated.The product investigation could not identify a root cause.The manufacturer internal reference number is: (b)(4).

• 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: 10698159
• MDR Text Key: 211933002
• Report Number: 1119421-2020-01497
• 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: other
• Type of Report: Initial,Followup,Followup
• Report Date: 12/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2022
• Device Model Number: AU00T0
• Device Lot Number: 12737623
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: HEALON GV.; UNSPECIFIED THREE PIECE IOL.; HEALON GV
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR