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

Model Number	ZCT225
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/22/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Explant date: if explanted, give date: not applicable as there is no indication that the lens was explanted.All pertinent information available to the manufacturer has been submitted.
Event or Problem Description
It was reported that after implantation of a zct225 8.0 diopter intraocular lens (iol), the lens had rotated 10 degrees.The initial axis of implantation was 97 degrees.At the one month post op visit, the axis was measured at 87 degrees.The patient did not report any issues.The lens remains implanted.No further information was provided.
Additional Manufacturer Narrative
Device evaluation: the device was not returned to the manufacturer for evaluation.Device inspection could not be performed, therefore the reported issue could not be verified.Manufacturing records were reviewed and the lens was manufactured according to specification.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.

• Brand Name: TECNIS
• Common Device Name: TORIC IOLS
• Manufacturer (Section D): ABBOTT MEDICAL OPTICS; santa ana CA
• MDR Report Key: 6451377
• Report Number: 9614546-2017-00263
• Device Sequence Number: 13626707
• Product Code: HQL
• UDI-Device Identifier: 05050474552494
• UDI-Public: (01)05050474552494(17)180916
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/04/2017

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: 09/16/2018
• Device Model Number: ZCT225
• Device Catalogue Number: ZCT225U080
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/15/2016
• Supplement Date Received by Manufacturer: 07/12/2017
• Initial Report FDA Received Date: 03/31/2017
• Supplement Report FDA Received Date: 08/04/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 61 YR