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

Model Number	ZCT225
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: unknown, not provided, but the best estimate date is during 2017.(b)(4).All pertinent information available to abbott medical optics has been submitted.
Event or Problem Description
It was reported that a zct225 17.0 diopter intraocular lens (iol) was explanted from the patient''s operative eye and replaced with another lens.No additional information was provided.
Additional Manufacturer Narrative
Additional information: in review of the file, it was found that this event was also reported in emdr report 9614546-2017-00413 and therefore, is a duplicate report.No further information will be reported under this mdr reporting number 9614546-2017-01164.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: 7061868
• Report Number: 9614546-2017-01164
• Device Sequence Number: 977598
• Product Code: HQL
• UDI-Device Identifier: 05050474552678
• UDI-Public: (01)05050474552678(17)210206
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/02/2018

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?: No
• Operator of Device: Physician
• Device Expiration Date: 02/06/2021
• Device Model Number: ZCT225
• Device Catalogue Number: ZCT225U170
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/30/2017
• Supplement Date Received by Manufacturer: 02/01/2018
• Initial Report FDA Received Date: 11/27/2017
• Supplement Report FDA Received Date: 03/02/2018
• 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: Required Intervention