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

Model Number	ZCT300
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	Blurred Vision (2137)
Date of Event	10/27/2017
Type of Reportable Event	Serious Injury
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 zct300 15.0 diopter intraocular lens (iol) was noticed rotated at the six month follow up visit with the doctor on (b)(6) 2017.The lens rotated from 108 degrees to 135 degrees post-operatively, which was a 27 degree change.The patient complained of moderate blurred vision at all distances.Reportedly, the patient complaint does not significantly interfere with activities of daily life.There was no patient complications or injury.No additional information was provided.The patient had bilateral lenses implanted.This report will capture the lens implanted in the patient's left eye.A separate report will be filed for the right eye.
Additional Manufacturer Narrative
An implant date of (b)(6) 2016 was reported in the initial emdr.Clarification on this date was provided and it was learned the actual date of implant was (b)(6) 2017.If implanted, give date: (b)(6) 2017.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 92705
• MDR Report Key: 7119992
• Report Number: 9614546-2017-01230
• Device Sequence Number: 16511288
• Product Code: HQL
• UDI-Device Identifier: 05050474553224
• UDI-Public: (01)05050474553224(17)180211
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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: health professional,study,use
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/11/2018

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: 02/11/2018
• Device Model Number: ZCT300
• Device Catalogue Number: ZCT300U150
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/16/2017
• Supplement Date Received by Manufacturer: 12/15/2017
• Initial Report FDA Received Date: 12/14/2017
• Supplement Report FDA Received Date: 01/12/2018
• 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: Other
• Patient Age: 62 YR