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

Model Number	ZCT600
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	06/14/2016
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
It was reported that a 18.0 diopter zct600 intraocular lens (iol) was explanted from patient's left eye and replaced with a 18.5 diopter zct300 iol.There was no incision enlargement, no sutures or other patient injury.No further information was provided.
Additional Manufacturer Narrative
Additional information: device available for evaluation  yes, returned to manufacturer on 09/30/2016.Device returned to manufacturer  yes.Device evaluation the device was returned to the manufacturer.Visual inspection with the unaided eye shows the lens is cut in pieces, most probably to make explant possible.Considering the condition of the lens additional analysis is not possible.The lens issue could not be confirmed in the returned sample.Manufacturing records were reviewed and the lens was manufactured according to specification.There were no non-conformances with respect to the manufacturing process.A search on complaints revealed no other complaints were received for this order number to date.Based on the investigation results there is no indication of a product quality deficiency.All pertinent information available to the manufacturer has been submitted.

• Brand Name: TECNIS
• Common Device Name: TORIC IOLS
• Manufacturer (Section D): ABBOTT MEDICAL OPTICS; santa ana CA
• MDR Report Key: 5901601
• Report Number: 9614546-2016-00412
• Device Sequence Number: 16144751
• Product Code: HQL
• UDI-Device Identifier: 05050474604124
• UDI-Public: (01)05050474604124(17)201105
• Combination Product (Y/N): N
• Initial Reporter State: ND
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/10/2016

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: 11/05/2020
• Device Model Number: ZCT600
• Device Catalogue Number: ZCT600U180
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/30/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 07/28/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/24/2016
• Supplement Report FDA Received Date: 11/10/2016
• 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: 67 YR