MAUDE Adverse Event Report: ALCON LABORATORIES, INC. ACRYSOF*IQ WITH ULTRASET; INTRAOCULAR LENS

Model Number AU00T0

Device Problem Folded (2630)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/03/2017

Event Type  malfunction  

Event Description

During cataract surgery, md was using a pre-loaded lens.Upon deploying the lens from the inserter, the lens remained folded.Md attempted to unfold lens but was unable and a new lens was used.No harm to patient.

• Type of Device: INTRAOCULAR LENS
• Manufacturer (Section D): ALCON LABORATORIES, INC.; 6201 south fwy.; ab2-12; fort worth TX 76134
• MDR Report Key: 6414684
• MDR Text Key: 70368262
• Report Number: 6414684
• Device Sequence Number: 1
• Product Code: KYB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2017
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 08/31/2019
• Device Model Number: AU00T0
• Device Catalogue Number: AU0010.230
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/16/2017
• Event Location: Hospital
• Date Report to Manufacturer: 01/16/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1