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

Model Number MA60AC

Device Problem Contamination of Device Ingredient or Reagent (2901)

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

Event Date 08/12/2019

Event Type  malfunction  

Manufacturer Narrative

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.The manufacturer internal reference number is: (b)(4).

Event Description

A customer reported an intraocular lens (iol) had a blot on it.A backup lens was used to complete the procedure.Additional information was requested.

Manufacturer Narrative

The lens was returned for evaluation.Solution is dried on the lens.The lens has been cut in half with a serrated knife, typical of insertion and removal from the eye.The lens was cleaned with lphse.A crack can be observed on each half.Multiple scratches are observed.Product history records were reviewed and the documentation indicated the product met release criteria.The root cause for the reported complaint could not be determined.The reported ¿blot¿ was not observed.It was stated the ¿blot¿ was observed when in the cartridge with a microscope; however, the lens has evidence that may indicate it was implanted and removed.Lens damage was observed.It is unknown if the damage may have been interpreted as the reported complaint.All lenses are 100% inspected for cosmetic attributes and the damage exhibited by the returned complaint sample would not have met approved release criteria.Due to the presence of surgical solution and the condition of the returned sample, the damage observed is most likely related to customer handling.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: 8939607
• MDR Text Key: 155991118
• Report Number: 1119421-2019-01369
• 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
• Report Date: 11/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2021
• Device Model Number: MA60AC
• Device Catalogue Number: MA60AC.115
• Device Lot Number: 12461959
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/28/2019
• Date Manufacturer Received: 11/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1