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

Model Number SN60WF

Device Problem Material Deformation (2976)

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

Event Date 10/11/2019

Event Type  malfunction  

Manufacturer Narrative

A sample device was not 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 reported in the lot number.Additional information has been requested.The manufacturer internal reference number is: (b)(4).

Event Description

A nurse reported that during an intraocular lens (iol) implant procedure, the lens was noted to be deformed after it was implanted.The iol was removed and replaced during the initial procedure with no patient harm.Additional information has been requested.

Manufacturer Narrative

Photo review: on the review of the attached picture, haptics appears to be broken.Small segments are visible detached.Deformation cannot be confirmed from the photo.The root cause for the reported complaint could not be determined as no sample was returned for analysis.No conclusion could be determined from the photo as a definitive determination of customer handling and damage cannot be made.A final root cause cannot be determined based on available information.All product and batch history records are quality reviewed prior to product release.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF IQ NATURAL 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: 9299415
• MDR Text Key: 177188202
• Report Number: 9612169-2019-00359
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 02/04/2020

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 Expiration Date: 08/31/2023
• Device Model Number: SN60WF
• Device Catalogue Number: SN60WF.210
• Device Lot Number: 21228290
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/14/2019
• Initial Date FDA Received: 11/08/2019
• Supplement Dates Manufacturer Received: 01/08/2020
• Supplement Dates FDA Received: 02/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1