MAUDE Adverse Event Report: ALCON RESEARCH, LTD. - HUNTINGTON ACRYSOF MULTIPIECE IOL; INTRAOCULAR LENS

Model Number MN60AC

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Complaint, Ill-Defined (2331)

Event Date 02/27/2018

Event Type  Injury  

Manufacturer Narrative

Evaluation summary: the iol product history records were reviewed and documentation indicates the product met release criteria.Cartridge product history record could not be reviewed because facility did not provide a lot number or any identification traceable to the manufacturing documentation.Root cause has not been identified.The manufacturer internal reference number is: (b)(4).

Event Description

An ophthalmologist reported that during a cataract extraction/intraocular lens (iol) implant procedure, while implanting in the sulcus, the lens was decentered inferiorly and sinking.It was suspected by the surgeon that the patient has zonulysis, therefore, the lens was removed and a different model iol was implanted during the initial procedure.Additional information was requested.

Manufacturer Narrative

Product evaluation: the product was returned.Solution is dried on the lens.Haptic damage was observed.Product history records were reviewed and the documentation indicated the product met release criteria.The customer indicated the use of a qualified cartridge, with a handpiece and a non-qualified viscoelastic.Cartridge product history record could not be reviewed because facility did not provide a lot number or any identification traceable to the manufacturing documentation.The root cause for the reported event could not be determined.A malfunction has not been indicated.(b)(4).

• Brand Name: ACRYSOF MULTIPIECE IOL
• Type of Device: INTRAOCULAR LENS
• Manufacturer (Section D): ALCON RESEARCH, LTD. - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• Manufacturer (Section G): ALCON RESEARCH, LTD. - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• Manufacturer Contact: nadia bailey ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8176152230
• MDR Report Key: 7365727
• MDR Text Key: 103313711
• Report Number: 1119421-2018-00318
• Device Sequence Number: 1
• Product Code: HQL
• Combination Product (y/n): N
• Reporter Country Code: MY
• PMA/PMN Number: P930014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 10/31/2020
• Device Model Number: MN60AC
• Device Catalogue Number: MN60AC.200
• Device Lot Number: 12405707
• Other Device ID Number: 00380655095119
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/27/2018
• Initial Date FDA Received: 03/23/2018
• Supplement Dates Manufacturer Received: 05/25/2018
• Supplement Dates FDA Received: 06/20/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/06/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: DISCOVISC; MONARCH II B CARTRIDGE; MONARCH III IOL DELIVERY SYSTEM
• Patient Outcome(s): Other