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

Model Number	ZCT400
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	08/02/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
All pertinent information available to abbott medical optics has been submitted.
Event or Problem Description
It was reported that specks and debris were noticed on an intraocular lens (iol) before loading it into the cartridge.No patient contact reported.No further information was provided.
Additional Manufacturer Narrative
Device available for evaluation? yes.Returned to manufacturer on: 09/16/2016.Device returned to manufacturer? yes.Device evaluation: the intraocular lens (iol) was returned at the manufacturing site for evaluation.Visual inspection revealed that the lens was contaminated with some foreign material and traces of liquid.The condition of the lens did not suggest that the foreign material was introduced during manufacturing.Manufacturing records review: the manufacturing records for the intraocular lens were reviewed.The product was manufactured and released according to specification.A search revealed that no additional complaints for this order number have been received.Labeling review: the directions for use (dfu) were reviewed.The directions for use (dfu) adequately provides instructions and precautions along with warnings for the proper use and handling of the device.As a result of the investigation there is no indication of a product quality deficiency.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: 5914914
• Report Number: 9614546-2016-00425
• Device Sequence Number: 22613
• Product Code: HQL
• UDI-Device Identifier: 05050474553989
• UDI-Public: (01)05050474553989(17)200519
• Combination Product (Y/N): N
• Initial Reporter State: HI
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/09/2016

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
• Operator of Device: Physician
• Device Expiration Date: 05/19/2020
• Device Model Number: ZCT400
• Device Catalogue Number: ZCT400U235
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/16/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 08/03/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/30/2016
• Supplement Report FDA Received Date: 11/10/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1