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 Known Impact Or Consequence To Patient (2692)

Event Date 07/04/2019

Event Type  malfunction  

Manufacturer Narrative

Evaluation summary: the product was not returned for analysis.Product history and batch records were reviewed and documentation indicated the product met release criteria.The product investigation could not identify a root cause.There have been no other complaints reported in the lot number.The manufacturer internal reference number is: (b)(4).

Event Description

A physician reported that during a cataract extraction with intraocular lens (iol) implant procedure, after implantation of the iol, a miniscule foreign substance was detected on the lens.

Manufacturer Narrative

Product evaluation: the product was not returned.A photo was provided of the lens in the eye.The photo has been attached to multiple files.The reporter does not know which occurrence this photo belongs to, thus it will be used as a reference.There are multiple dark areas around the edge of the optic that may be damage/foreign material.It cannot be determined if this is on the anterior or posterior side.Without the actual sample we cannot determine if this is a damage or foreign material as reported.Product history records were reviewed and the documentation indicated the product met release criteria.Associated products were not provided.It is unknown if qualified products were used.Based on our observation of the attached photo, we cannot determine if this is a damage or foreign material as reported.The root cause cannot be determined based on available information.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: 8846143
• MDR Text Key: 153104674
• Report Number: 1119421-2019-01236
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2023
• Device Model Number: SN60AT
• Device Catalogue Number: SN60AT.225
• Device Lot Number: 12676756
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/03/2019
• Initial Date FDA Received: 07/31/2019
• Supplement Dates Manufacturer Received: 09/15/2019
• Supplement Dates FDA Received: 10/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1