MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON ACRYSOF SINGLEPIECE IOL; INTRAOCULAR LENS

Model Number SN60AT

Device Problem Contamination of Device Ingredient or Reagent (2901)

Patient Problem No Patient Involvement (2645)

Event Date 07/29/2019

Event Type  malfunction  

Manufacturer Narrative

A sample product was not returned for analysis.The iol product history records were reviewed and documentation indicates the product met release criteria.Root cause has not been identified.There are no other complaints in the lot.The manufacturer internal reference number is: (b)(4).

Event Description

A surgeon reported that before an intraocular lens (iol) implant procedure, foreign material was adhered to the iol.Another lens was implanted instead.There was no patient involved.

Manufacturer Narrative

The product was returned.Solution with two small fibers was observed dried on the lens.Haptic damage was also observed.The customer indicated the use of a qualified cartridge.The product investigation could not identify a root cause.The fibers were observed dried in the solution on the lens.It is unknown if the fibers were the reported foreign material.Due to the condition of the returned sample, solution dried on both sides is an indication the product was handled, we cannot verify the particulate was present when opened.The origin is unknown.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF SINGLEPIECE IOL
• Type of Device: INTRAOCULAR LENS
• Manufacturer (Section D): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• MDR Report Key: 8935863
• MDR Text Key: 156001337
• Report Number: 1119421-2019-01364
• Device Sequence Number: 1
• Product Code: HQL
• 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: 11/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2021
• Device Model Number: SN60AT
• Device Catalogue Number: SN60ATQ285
• Device Lot Number: 12506531
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2019
• Date Manufacturer Received: 11/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: MONARCH II C CARTRIDGES, 8065977759, HWV