MAUDE Adverse Event Report: ALCON LABORATORIES, INC. ACRYSOF®; INTRAOCULAR LENS

Model Number SN6AT4

Device Problems Manufacturing, Packaging or Shipping Problem (2975); Material Twisted/Bent (2981)

Patient Problem Insufficient Information (4580)

Event Date 11/03/2021

Event Type  malfunction  

Event Description

Intraocular lens bent in packaging from manufacturer.Manufacturer response for iol, (brand not provided) (per site reporter).They took down description of the problem, removed the lens from consignment & issued a returned goods authorization number.

• Brand Name: ACRYSOF®
• Type of Device: INTRAOCULAR LENS
• Manufacturer (Section D): ALCON LABORATORIES, INC.; 6201 south freeway; fort worth TX 76134
• MDR Report Key: 13522882
• MDR Text Key: 285542958
• Report Number: 13522882
• Device Sequence Number: 1
• Product Code: HQL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/29/2021

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 Model Number: SN6AT4
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/30/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/29/2021
• Event Location: Hospital
• Date Report to Manufacturer: 02/14/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/14/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 23725 DA
• Patient Sex: Female