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

Model Number	ZCT150
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	02/27/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The intraocular lens was not implanted.(b)(4).All pertinent information available to abbott medical optics has been submitted.
Event or Problem Description
It was reported that the intraocular lens (iol) had lathe marks on the optic area.The event was noticed during handling but prior to insertion.No patient contact.No additional information was provided to abbott medical optics.
Additional Manufacturer Narrative
Additional info/corrected data: in review of the file, it was found that this event reported is a duplicate of previously reported event, under complaint (b)(4), and manufacturing report number: 9614546-2017-00221.Therefore, no further information will be submitted under this file.All pertinent information was submitted under complaint (b)(4) and manufacturing report number 9614546-2017-00221.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: 6437900
• Report Number: 2648035-2017-00572
• Device Sequence Number: 16294349
• Product Code: HQL
• UDI-Device Identifier: 05050474552104
• UDI-Public: (01)05050474552104(17)210108
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 10/11/2017

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: 01/08/2021
• Device Model Number: ZCT150
• Device Catalogue Number: ZCT150U180
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/27/2017
• Supplement Date Received by Manufacturer: 09/18/2017
• Initial Report FDA Received Date: 03/27/2017
• Supplement Report FDA Received Date: 10/11/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1