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

Model Number	ZCT150
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/01/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lens was inserted and removed.All pertinent information available to abbott medical optics has been submitted.
Event or Problem Description
It was reported that during the implantation of an intraocular lens (iol), debris was observed on the lens.Additional information was received and it was learnt that the iol was fully inserted and removed.No incision enlargement, no vitrectomy was performed, no suture was used and no patient injury was reported.Another lens was implanted successfully, same model and diopter size.No further information was provided.
Additional Manufacturer Narrative
Device available for evaluation? yes.Returned to manufacturer on: 07/13/2017.Device returned to manufacturer? yes.Device evaluation: the intraocular lens (iol) was returned at the manufacturing site for evaluation.Visual inspection at 12x microscope magnification showed that the lens was cut in half, most probably to make the removal possible.It could be seen that the lens was contaminated.Contamination as dust and particles is expected as the lens was transported from a controlled environment during manufacturing to a non-sterile, non-environmentally controlled area.The investigation of the return sample does not suggest that the contamination 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 similar complaints for this order number have been received.Labeling review: the directions for use (dfu) adequately provides instructions and precautions along with warnings for the proper use and handling of the device.The dfu states to examine the lens thoroughly to ensure particles have not become attached to it, and examine the lens optical surfaces for other defects.As a result of the investigation there is no indication of a product quality deficiency and the reported issue could not be verified.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: 6669086
• Report Number: 9614546-2017-00568
• Device Sequence Number: 603951
• Product Code: HQL
• UDI-Device Identifier: 05050474551930
• UDI-Public: (01)05050474551930(17)200426
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 10/13/2017

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: 04/26/2020
• Device Model Number: ZCT150
• Device Catalogue Number: ZCT150U095
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2017
• Initial Date Received by Manufacturer: 06/05/2017
• Supplement Date Received by Manufacturer: 09/18/2017
• Initial Report FDA Received Date: 06/27/2017
• Supplement Report FDA Received Date: 10/13/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1