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

Model Number MA50BM

Device Problem Scratched Material (3020)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/20/2020

Event Type  malfunction  

Manufacturer Narrative

A sample device was not returned for analysis.Complaint history and product history records were reviewed and documentation indicated the product met release criteria.Root cause has not been identified.There have been no other complaints reported in the lot number.Additional information has been requested.(b)(4).

Event Description

A nurse reported that during an intraocular lens (iol) implant procedure, a mark was noticed on the optic after it was implanted.The iol was removed and replaced with a backup lens to complete the procedure.Additional information was requested.

Manufacturer Narrative

Product evaluation: the customer indicated the use of an non- qualified cartridge.The iol model is only qualified for use in a specific cartridge model.The root cause is most likely a failure to follow the dfu.The account used a non-qualified lens/cartridge combination.The use of non-qualified combinations may result in delivery issues and/or damage.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
• MDR Report Key: 10404658
• MDR Text Key: 203455694
• Report Number: 1119421-2020-01132
• 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: 10/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2024
• Device Model Number: MA50BM
• Device Catalogue Number: MA50BM.140
• Device Lot Number: 12690290
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: MONARCH II B CARTRIDGES; PROVISC VIS SOLUTION 0.85ML