MAUDE Adverse Event Report: ABBOTT MEDICAL OPTICS TECNIS; TORIC IOLS

Model Number	ZCT150
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	12/05/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).All pertinent information available to abbott medical optics has been submitted.
Event or Problem Description
It was reported that the intraocular lens (iol) was explanted due to complications.No further information was provided.
Additional Manufacturer Narrative
An empty box was returned.Visual inspection with the unaided eye shows the lens box of the product was empty.The reported issue could not be confirmed.Manufacturing records were reviewed and the lens was manufactured according to specification.A search on complaints revealed that no similar complaints were received for this production order number.The directions for use (dfu) was reviewed.The dfu adequately provides instructions and precautions for the proper use and handling of the device.Based on the investigation results there is no indication of a product quality deficiency.All pertinent information available to the manufacturer has been submitted.
Additional Manufacturer Narrative
Upon further review it was observed that in follow up report #1 within the device evaluation narrative it was noted that a labeling review was conducted.Clarification was requested for the evaluation results and it was determined that a labeling review was in fact not conducted as part of the device evaluation for this complaint.All pertinent information available to abbott medical optics has been submitted.

• Brand Name: TECNIS
• Common Device Name: TORIC IOLS
• Manufacturer (Section D): ABBOTT MEDICAL OPTICS; santa ana CA
• MDR Report Key: 6447397
• Report Number: 9614546-2017-00255
• Device Sequence Number: 13597884
• Product Code: HQL
• UDI-Device Identifier: 05050474552043
• UDI-Public: (01)05050474552043(17)180505
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/30/2017

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?: No
• Operator of Device: Physician
• Device Expiration Date: 05/05/2018
• Device Model Number: ZCT150
• Device Catalogue Number: ZCT150U150
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/02/2017
• Supplement Date Received by Manufacturer: 06/09/2017; 08/07/2017
• Initial Report FDA Received Date: 03/30/2017
• Supplement Report FDA Received Date: 06/30/2017; 08/31/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention