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

Model Number SA60AT

Device Problem Material Deformation (2976)

Patient Problem No Code Available (3191)

Event Type  malfunction  

Manufacturer Narrative

Evaluation summary: the product was not returned for analysis.The complaint history and product history records could not be reviewed because the reporting facility did not provide a lot number or any identification traceable to the manufacturing documentation.The product investigation could not identify a root cause.Additional information has been requested.The manufacturer internal reference number is: (b)(4).

Event Description

A consumer reported that after an intraocular lens (iol) implant surgery, she experienced facial trauma and the iol's became opaque in both eyes.One eye had a lens exchange but it is unknown which eye at this time.This record is for the second eye without the lens exchange.Additional information has been requested.

Manufacturer Narrative

The manufacturer internal reference number is: (b)(4).

Event Description

Additional information has been requested and received stating on (b)(6) 2015, i was ran over by a motorcycle, at the hospital the next morning, i could see clear.They admitted me for various fractures including the orbit.After 24 hours, i began to no longer see as it was all blurred, i could not distinguishing anything.Since then, it has always been this way.In parma, doctor (b)(6) gave me the diagnosis of opaque lens.The lens were implanted in 2006.

Manufacturer Narrative

The product was not returned.Product history records were reviewed and documentation indicated the product met release criteria.Root cause: the product investigation could not identify a root cause.Information provided in the file (by the patient) states both eyes were opaque after a facial trauma.No further information has been obtainable.The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

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: 9417314
• MDR Text Key: 176037208
• Report Number: 1119421-2019-02045
• 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,Followup,Followup
• Report Date: 01/27/2020

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: 05/31/2010
• Device Model Number: SA60AT
• Device Catalogue Number: SA60AT.105
• Device Lot Number: 904347
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 11/26/2019
• Initial Date FDA Received: 12/05/2019
• Supplement Dates Manufacturer Received: 01/22/2020; 01/22/2020; 01/24/2020
• Supplement Dates FDA Received: 12/20/2019; 01/22/2020; 01/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1