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

Model Number SA60AT

Device Problem Defective Component (2292)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

The manufacturing device history records (dhr) were reviewed and shows that the product met specification prior to release and shows no other complaints in this lot.A product sample was not returned therefore, the reported event cannot be confirmed.The root cause of the reported event cannot be determined; however, should additional reportable information become available, a supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56.The manufacturer internal reference number is: (b)(4).

Event Description

A healthcare professional reported that the intraocular lens was defective and was not placed during a procedure.Additional information has been requested however, further information has not been received.

Event Description

Additional information was received indicating that when the surgeon opened the wagon-wheel box, the lens was out of shape.There was no patient contact.An alternate iol was used to complete the procedure.

Manufacturer Narrative

This event does not meet criteria as a reportable malfunction based on information received following submission of the initial report.The manufacturer internal reference number is: (b)(4).

• 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
• MDR Report Key: 10323180
• MDR Text Key: 201880103
• Report Number: 9612169-2020-00161
• Device Sequence Number: 1
• Product Code: HQL
• Combination Product (y/n): N
• PMA/PMN Number: P930014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 07/27/2020

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: SA60AT
• Device Catalogue Number: SA60AT.220
• Device Lot Number: 21267547
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/17/2020
• Initial Date FDA Received: 07/24/2020
• Supplement Dates Manufacturer Received: 07/27/2020
• Supplement Dates FDA Received: 07/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1