MAUDE Adverse Event Report: ALCON RESEARCH, LLC - 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 Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

The device was received by a company representative and is in transit to the manufacturing site for investigation.Investigation including root cause analysis will be completed.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.Complaint history and product history records were reviewed and documentation indicated the product met release criteria.There are no other complaints in the lot.(b)(4).

Event Description

A facility representative reported that during an intraocular lens (iol) implant procedure, the plunger was "stiff" with resistance.It is unknown as to whether the device came into contact with the patient.Additional information was requested.

Manufacturer Narrative

The device and the lens were returned separated.The plunger is oriented correctly.Viscoelastic is observed in the device.The plunger has been retracted to the fill line.No damage is observed.The nozzle was removed and cleaned for further evaluation.Top coat dye stain testing was conducted with acceptable results.The lens was outside of the device.Viscoelastic is observed on the lens.Both haptics are folded in adhered to the anterior surface with viscoelastic.One haptic is broken-gusset area.It cannot be determined when the haptic damage occurred.A non-qualified viscoelastic was indicated.The device was evaluated and no plunger damage or abnormalities were observed.Top coat dye stain testing was conducted with acceptable results.The plunger and lens position during advancement cannot be determined because the lens was returned outside of the device.The root cause for the reported "plunger was stiff" may be related to a failure to follow the dfu.A non-qualified viscoelastic was used.Material properties of a non-qualified viscoelastic may contribute to underfill, overfill, misfolding of the trailing haptic, lack of lubricity or other unpredictable outcomes.No damage was observed.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, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• MDR Report Key: 8492868
• MDR Text Key: 141313734
• Report Number: 1119421-2019-00436
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 07/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2023
• Device Model Number: SN6CWS
• Device Catalogue Number: SN6CWS.220
• Device Lot Number: 12645222
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/28/2019
• Date Manufacturer Received: 07/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PROVISC