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

Model Number	ZCT300
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/18/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Explant date: if explanted, give date: not applicable, as the lens was remains implanted all pertinent information available to abbott medical optics has been submitted.
Event or Problem Description
During a study visit, patient intraocular lens (iol) measurement was performed and the slit lamp measured the iol at 29 degrees.Which was 14 degrees from the operational placement of 15 degrees.There was no physician or patient complaint.Patient's best corrected distance visual acuity (bcdva) is 20/20 od (right eye).The iol remains implanted.There were no impairment reported and the surgery outcome did not significantly interfere with patient's activities of daily life.
Additional Manufacturer Narrative
Device evaluation: the device was not returned to the manufacturer for evaluation as 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.The complaint history search revealed no other complaints for this production order number has been received.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: 6165575
• Report Number: 9614546-2016-00676
• Device Sequence Number: 829652
• Product Code: HQL
• UDI-Device Identifier: 05050474553361
• UDI-Public: (01)05050474553361(17)170924
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/09/2017

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: 09/24/2017
• Device Model Number: ZCT300
• Device Catalogue Number: ZCT300U220
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 11/15/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/12/2016
• Supplement Report FDA Received Date: 01/09/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 73 YR