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

Model Number	ZCT400
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/22/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lens remains implanted.All pertinent information available to abbott medical optics has been submitted.
Event or Problem Description
It was reported that a zct400 20.5 diopter intraocular lens (iol) was noticed rotated from its initial 160 degrees placement to 4 degrees in the patient's left eye (os) at the 6-month visit with the doctor.The lens was implanted (b)(6) 2017.Reportedly, there was no patient complications or related injury and the outcome does not significantly interfere with activities of daily life for the patient.There are no plans at the moment to reposition the lens.No additional information was provided.
Additional Manufacturer Narrative
Device evaluation: visual inspection/product testing could not be performed as the product was not returned for evaluation.The reported complaint could not be verified.Manufacturing record review: manufacturing records were reviewed and the lens was manufactured according to specification.A search on complaints revealed no similar complaints were received for this production order number to date.Labeling review: the directions for use (dfu) was reviewed.The dfu adequately provides instructions and precautions for the proper use and handling of the intraocular lenses.Conclusion: based on the investigation results there is no indication of a product quality deficiency.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS
• Common Device Name: TORIC IOLS
• Manufacturer (Section D): ABBOTT MEDICAL OPTICS; santa ana CA 92705
• MDR Report Key: 7291308
• Report Number: 9614546-2018-00178
• Device Sequence Number: 2378566
• Product Code: HQL
• UDI-Device Identifier: 05050474553927
• UDI-Public: (01)05050474553927(17)200725
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/09/2018

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: 07/25/2020
• Device Model Number: ZCT400
• Device Catalogue Number: ZCT400U205
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/26/2018
• Supplement Date Received by Manufacturer: 03/12/2018
• Initial Report FDA Received Date: 02/22/2018
• Supplement Report FDA Received Date: 04/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 87 YR