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

Model Number MN60AC

Device Problems Dent in Material (2526); Material Twisted/Bent (2981)

Patient Problem Visual Impairment (2138)

Event Date 01/20/2020

Event Type  Injury  

Manufacturer Narrative

A sample product 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 are no other complaints in the lot.The manufacturer internal reference number is: (b)(4).

Event Description

A surgeon reported that during an intraocular lens (iol) implantation, the leading haptic was stuck in injector and became dented and bent.The patient was left aphakic with a plan to implant another lens at a later date.Additional information was requested.

Manufacturer Narrative

Corrected information was provided in d.11.The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

The lens was returned positioned incorrectly in the lens case.Solution is dried on the lens.One haptic is bent in the distal area.The qualified cartridge was not returned for evaluation.Qualified associated products were indicated.Viscoelastic was not provide.It is unknown if a qualified product was used.The root cause for the reported event ¿haptic stuck inside the injector¿ could not be determined.The lens was not returned in the condition reported.The lens was returned in the lens case.A bent haptic was observed.The haptic position during advancement cannot be determined.The qualified associated cartridge was not returned for evaluation.All lenses are 100% inspected for cosmetic attributes and the damage exhibited by the returned complaint sample would not have met release criteria.Based on our observation, and the review of manufacturing records, it can be reasonably concluded that the damage is not manufacturing related.Additional information was provided in d.10., h.3., h.6.And h.10.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: 9746710
• MDR Text Key: 181160981
• Report Number: 1119421-2020-00283
• 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: foreign,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 12/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2023
• Device Model Number: MN60AC
• Device Catalogue Number: MN60AC.190
• Device Lot Number: 12650147
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2020
• Date Manufacturer Received: 12/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: MONARCH CARTRIDGES.; MONARCH II B CARTRIDGE.; MONARCH III IOL DELIVERY SYST.
• Patient Outcome(s): Other