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

Model Number	ZCT400
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Code Available (3191)
Date of Event	09/26/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If explanted, give date: not applicable, as 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 intraocular lens (iol) was implanted in a female patient's right eye on (b)(6) 2016.At surgery the lens was at 106 degrees.During a routine medical examination on (b)(6) 2016, the physician noticed the lens rotated to 155 degrees, a difference of 49 degrees.There was no patient complications.The surgery outcome did not significantly interfered with patients activities of daily life.The patient had no complaints at 1 month post-op.The lens was re- positioned on (b)(6) 2016.
Additional Manufacturer Narrative
(b)(4).Report source: study was inadvertently not entered.Device evaluation the device was not returned to the manufacturer for evaluation as the lens remains implanted.Visual inspection could not be performed, therefore the reported complaint could not be verified.Manufacturing records were reviewed and the lens was manufactured according to specification.There were no non conformances with respect to the manufacturing process.There are no associated nonconformity reports or deviations.A search on complaints revealed no other complaints were received for this order number to date.The directions for use (dfu) was reviewed.The dfu adequately provides instructions and precautions for the proper use and handling of the intraocular lenses.Based on the investigation results 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: 6048792
• Report Number: 9614546-2016-00539
• Device Sequence Number: 18911176
• Product Code: HQL
• UDI-Device Identifier: 05050474553903
• UDI-Public: (01)05050474553903(17)171213
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: health professional,study,use
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/17/2016

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?: Yes
• Operator of Device: Physician
• Device Expiration Date: 12/13/2017
• Device Model Number: ZCT400
• Device Catalogue Number: ZCT400U195
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 09/26/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/21/2016
• Supplement Report FDA Received Date: 11/17/2016
• 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
• Patient Age: 74 YR