MAUDE Adverse Event Report: ALCON RESEARCH, LTD. - HUNTINGTON ACRYSOF IQ SINGLEPIECE IOL W/ACRYSERT C DELIVERY SYSTEM; LENS, GUIDE, INTRAOCULAR

Model Number SN6CWS

Device Problem Material Too Rigid or Stiff (1544)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/31/2018

Event Type  malfunction  

Manufacturer Narrative

A sample device 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.Additional information was requested.(b)(4).

Event Description

A nurse reported that during the injection of an intraocular lens (iol), the surgeon felt that the plunger was stiff.The lens was successfully implanted without any harm to the patient.Additional information was requested.

Manufacturer Narrative

A non-qualified viscoelastic was indicated.The root cause for the reported ¿stiff plunger¿ may be related to a failure to follow the dfu.Material properties of a non-qualified viscoelastic may contribute to underfill, overfill, misfolding of the trailing haptic, lack of lubricity or other unpredictable outcomes.Additional information was provided.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF IQ SINGLEPIECE IOL W/ACRYSERT C 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: nadia bailey ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8176152230
• MDR Report Key: 7296519
• MDR Text Key: 101122794
• Report Number: 1119421-2018-00212
• Device Sequence Number: 1
• Product Code: KYB
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P930014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 05/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2021
• Device Model Number: SN6CWS
• Device Catalogue Number: SN6CWS.200
• Device Lot Number: 12483926
• Other Device ID Number: 00380652249218
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/30/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/22/2016
• 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