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

Model Number	ZCT150
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Visual Disturbances (2140); No Code Available (3191)
Date of Event	03/29/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).All pertinent information available to abbott medical optics has been submitted.
Event or Problem Description
A report was received that a tecnis monofocal model zct150 intraocular lens (iol) was explanted from a patient¿s operative eye as there was visual disturbances and expected (wanted) near vision.Although attempts were made, no additional information was provided.
Additional Manufacturer Narrative
Device available for evaluation ¿ yes, returned to manufacturer on 03/07/2017.Device returned to manufacturer ¿ yes.Device evaluation: the device was returned to the manufacturer.Visual inspection with the unaided eye shows the product is cut in pieces, most probably to make explant possible.Considering the condition of the lens additional analysis is not possible.Manufacturing records were reviewed and the lens was manufactured according to specification.A search on complaints revealed that no similar complaints have been received for this production order number.The directions for use (dfu) was reviewed.The dfu adequately provides instructions and precautions for the proper use and handling of the device.Based on the investigation results there is no indication of a product quality deficiency.All pertinent information available to the manufacturer has been submitted.
Additional Manufacturer Narrative
Corrected data: physician name and patient data was inadvertently not reported in the first supplemental report.According to the additional information received, the physician noted that the patient wanted an advance mf (multifocal) lens.The zct150 iol was explanted and replaced with a zxt150 iol with a higher diopter.Age/date of birth: (b)(6).Gender/sex: male.Physician name: dr.(b)(6).All pertinent information available to abbott medical optics has been submitted.
Additional Manufacturer Narrative
In mdr follow up #2 the following was identified: date of this report, a date of 08/15/2017, was entered; however, the correct date of the submitted report was actually 08/17/2017.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
• MDR Report Key: 6521099
• Report Number: 9614546-2017-00323
• Device Sequence Number: 1330967
• Product Code: HQL
• UDI-Device Identifier: 05050474552173
• UDI-Public: (01)05050474552173(17)201229
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 09/11/2017

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: 12/29/2020
• Device Model Number: ZCT150
• Device Catalogue Number: ZCT150U215
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2017
• Initial Date Received by Manufacturer: 03/29/2017
• Supplement Date Received by Manufacturer: 06/23/2017; 07/24/2017; 08/17/2017
• Initial Report FDA Received Date: 04/25/2017
• Supplement Report FDA Received Date: 07/19/2017; 08/17/2017; 09/11/2017
• 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: 53 YR