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 08/10/2019

Event Type  malfunction  

Manufacturer Narrative

Evaluation summary: the product was not returned for analysis.The 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 doctor reported that during a cataract surgery with intraocular lens (iol) implant procedure, foreign material was found on the optic after iol implantation.Additional information has was provided that the size of foreign materials are various.Some of them are small and some materials are 1/2, 1/3 of the haptic size.The foreign material's color is yellow as same as iol and it is stuck on the optic.It is hard to remove them because it takes more than 5 mins.The iol, which is with the foreign material was placed to towards patient's eyelid or ccc margin for not affecting patient.The iol is implanted.There are six medical device reports associated with the events reported.This report is one of six.

Manufacturer Narrative

Evaluation summary: the product was not returned.The customer indicated the used of a non-qualified lens\cartridge combination.It was also indicated that a non-qualified viscoelastic was used.The reported "foreign material" could not be verified.No sample was returned.The root cause for the reported issue may be related to a failure to follow the directions for use (dfu).The use of non-qualified combinations may cause damage to the lens and potential complications during the implantation process.The "foreign material' was indicated to be "yellow" like the lens.This may indicate lens material from damage due to use of the non-qualified products.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: 8974922
• MDR Text Key: 157119328
• Report Number: 1119421-2019-01445
• 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: 11/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2024
• Device Model Number: SN60AT
• Device Catalogue Number: SN60AT.190
• Device Lot Number: 12698066
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: MONARCH III D CARTRIDGES, 8065977763, HWV; MONARCH III IOL DELIVERY SYST, 8065977773, APD; UNIAL