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 Patient Involvement (2645)

Event Date 12/12/2018

Event Type  malfunction  

Manufacturer Narrative

Product history records were reviewed and documentation indicated the product met release criteria.Root cause has not been identified.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.There are no other complaints in the lot.The manufacturer internal reference number is: (b)(4).

Event Description

A nurse manager reported that during an intraocular lens (iol) implant procedure, the injector was "stiff" during priming and shot the lens out onto the table.There was no patient involved.

Manufacturer Narrative

The device and the lens were returned separated.The lens stop has been removed.The plunger is oriented correctly.Viscoelastic is observed in the device.The plunger has been fully advanced outside of the tip.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 returned taped to the outside of the device.Viscoelastic is observed.The lens was cleaned with lphse to remove from the tape.No lens damage was observed.The lens dimensions are acceptable (plan view) using an approved template.No problems were found with the returned device or lens.No device or lens damage was found.The lens dimensions are acceptable (plan view) using an approved template.Nozzle top coat dye stain testing was conducted with acceptable results.The root cause for the reported issue may be related to a failure to follow the dfu.A non-qualified viscoelastic was used in the device.Material properties of non-qualified ovds may contribute to underfill, overfill, misfolding of the haptics, or other inconsistent folding outcomes.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
• MDR Report Key: 8297852
• MDR Text Key: 135153319
• Report Number: 1119421-2019-00126
• 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: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 04/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2019
• 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.250
• Device Lot Number: 12645271
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2019
• Date Manufacturer Received: 04/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: EYEFILL MB 'GREEN"