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

Model Number SN60AT

Device Problems Device Contamination with Chemical or Other Material (2944); Sharp Edges (4013)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Manufacturer Narrative

The sample has not been 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 have been no other complaints in the reported lot number.The manufacturer internal reference number is: (b)(4).

Event Description

A physician reported, there was a cut edge with a "string" hanging off where haptic comes off the optic.It seemed sharp so the physician grabbed it and peeled it off smoothly.The surgeon reports it happened a second time with a different lens the same day.Additional information is requested.There are two related reports for this facility.This report addresses the first event and an additional report will be filed.

Manufacturer Narrative

Corrected data in h.6.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF SINGLEPIECE IOL
• Type of Device: INTRAOCULAR LENS
• Manufacturer (Section D): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• MDR Report Key: 11465559
• MDR Text Key: 239396564
• Report Number: 1119421-2021-00533
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 00380650130112
• UDI-Public: 00380650130112
• Combination Product (y/n): N
• PMA/PMN Number: P930014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 04/20/2021

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 Operator: Health Professional
• Device Model Number: SN60AT
• Device Catalogue Number: SN60AT.105
• Device Lot Number: 12734253
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/16/2021
• Initial Date FDA Received: 03/11/2021
• Supplement Dates Manufacturer Received: 04/16/2021
• Supplement Dates FDA Received: 04/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1