MAUDE Adverse Event Report: ALCON RESEARCH, LTD. ACRYSOF; INTRAOCULAR LENS

Model Number AU00T0

Device Problems Bent (1059); Difficult to Insert (1316); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/09/2017

Event Type  malfunction  

Event Description

Lens comes preloaded to avoid any human touch and prevent scratches on the lens surface.It is supposed to fold in a way that facilitates insertion.The front haptic was bent to the right side, but should have been folded to the left side.I had to stop insertion and manually reposition the haptic properly in the bag.There was no risk or danger to the patient but the preloaded implant is supposed to make insertion easier.In this case it did not fulfill its purpose.

• Brand Name: ACRYSOF
• Type of Device: INTRAOCULAR LENS
• Manufacturer (Section D): ALCON RESEARCH, LTD.; 6065 kyle lane; huntington WV 25702
• MDR Report Key: 6272681
• MDR Text Key: 65606164
• Report Number: 6272681
• Device Sequence Number: 1
• Product Code: HQL
• 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: 01/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 02/28/2019
• Device Model Number: AU00T0
• Other Device ID Number: +21.5 DIOPTER
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/11/2017
• Device Age: 1 DY
• Event Location: Ambulatory Surgical Facility
• Date Report to Manufacturer: 01/11/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/24/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1