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

Model Number MA60MA

Device Problem Defective Component (2292)

Patient Problem Insufficient Information (4580)

Event Date 10/25/2019

Event Type  malfunction  

Manufacturer Narrative

Product evaluation: the used lens was returned.Solution is dried on the lens.One haptic is bent-gusset area.All product and batch history records are quality reviewed prior to product release.The customer indicate the use of a non-qualified cartridge and handpiece.The lens model is only qualified for use in the cartridge.The root cause for the observed haptic damage appears to be related to a failure to follow the dfu.The model was only qualified for use in the cartridge.The use of a non-qualified iol/handpiece combination can lead to delivery issues and/or product damage.There have been no other complaints reported in the lot number.(b)(4).

Event Description

A facility representative reported an intraocular lens was noticed it was misshaped after lens placed in eye, additional information has been requested.

• 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 ; 8175514979
• MDR Report Key: 10935617
• MDR Text Key: 219366445
• Report Number: 1119421-2020-01818
• Device Sequence Number: 1
• Product Code: HQL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P930014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 12/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MA60MA
• Device Catalogue Number: MA60MA.040
• Device Lot Number: 12726489
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2020
• Date Manufacturer Received: 11/05/2020
• Date Device Manufactured: 07/16/2019
• 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
• Patient Age: 81 YR