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

Model Number MA60AC

Device Problem Material Deformation (2976)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Manufacturer Narrative

The product has not been returned for analysis.Complaint history and product history record could not be reviewed because the reporting facility did not provide a valid 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

A customer reported a lens that was folded and had a defect.Additional information is requested.

Manufacturer Narrative

The lens was returned positioned incorrectly in the lens case.Viscoelastic was dried on the lens.One haptic was bent in the distal area.The optic has a split area near the optic edge.The associated non-qualified cartridge was also returned.Viscoelastic was dried in the cartridge.The cartridge displayed evidence of being placed into a handpiece.Product history records were reviewed and the documentation indicated the product met release criteria.A non-qualified cartridge was used with the lens.The lens is only qualified for use in the a and b cartridges.The associated handpiece and viscoelastic products are unknown.The root cause for the reported complaint was most likely related to a failure to follow the ifu.A non-qualified cartridge was used with the lens.The ifu instructs that a company qualified delivery system and viscoelastic combination should be used.The use of an unqualified combination may cause damage to the lens and potential complications during the implantation process.Company recommends using the qualified iol delivery system or any other company qualified combination.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF MULTIPIECE IOL
• Type of Device: INTRAOCULAR LENS
• Manufacturer (Section D): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• Manufacturer (Section G): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 10706415
• MDR Text Key: 213689864
• Report Number: 1119421-2020-01502
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 00380652552561
• UDI-Public: 00380652552561
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: P930014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 07/07/2022

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: Other
• Device Expiration Date: 12/31/2023
• Device Model Number: MA60AC
• Device Catalogue Number: MA60AC.220
• Device Lot Number: 12686787
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: 09/29/2020
• Initial Date FDA Received: 10/20/2020
• Supplement Dates Manufacturer Received: 06/15/2022
• Supplement Dates FDA Received: 07/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/31/2019
• 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: MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE C