MAUDE Adverse Event Report: ALCON LABORATORIES IRELAND LTD. ACRYSOF SINGLEPIECE IOL; INTRAOCULAR LENS

Model Number SA60AT

Device Problem Fracture (1260)

Patient Problem Capsular Bag Tear (2639)

Event Date 01/15/2019

Event Type  Injury  

Manufacturer Narrative

Evaluation summary: the product was not returned for analysis.Product history and batch records were reviewed and documentation indicated the product met release criteria.The product investigation could not identify a root cause.There have been no other complaints reported in the lot number.The manufacturer internal reference number is: (b)(4).

Event Description

A facility representative reported that during an intraocular lens (iol) implant procedure, the lens was injected into the anterior chamber and rupture of the posterior capsule occurred.The lens is hanging.The lens is recovered and the doctor tried to place in the anterior chamber but there is no support and the lens fractured.The lens is removed and a different model is placed.

• Brand Name: ACRYSOF SINGLEPIECE IOL
• Type of Device: INTRAOCULAR LENS
• Manufacturer (Section D): ALCON LABORATORIES IRELAND LTD.; cork business&technology park; model farm road; cork 00000 ; EI 00000
• Manufacturer (Section G): ALCON LABORATORIES IRELAND LTD.; cork business&technology park; model farm road; cork 00000 ; EI 00000
• Manufacturer Contact: cindy milam ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8176152231
• MDR Report Key: 8330479
• MDR Text Key: 135862044
• Report Number: 9612169-2019-00018
• Device Sequence Number: 1
• Product Code: HQL
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: P930014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2023
• Device Model Number: SA60AT
• Device Catalogue Number: SA60AT.225
• Device Lot Number: 21225853
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/17/2019
• Initial Date FDA Received: 02/12/2019
• Date Device Manufactured: 09/06/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other