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

Model Number	ZXT150
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	07/26/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Three (3) attempts have been made to obtain missing information; however, to date, no response has been received.All pertinent information available to abbott medical optics has been submitted.
Event or Problem Description
It was reported that an intraocular lens (model zxt150, +16.5 diopter) was explanted in a secondary surgical procedure, because the patient was not happy with the outcome.Reportedly, a different lens with the same diopter size was implanted as a replacement.No further information was provided.
Additional Manufacturer Narrative
Additional information was received and it was learnt that the intraocular lens was implanted in the eye of a male patient on (b)(6) 2016.Reportedly, the patient's vision was not clear even with the glasses, and he was experiencing starbusts.The lens was exchange on (b)(6) 2017.No incision enlargements, no sutures were used and no patient post-op injury was reported.No further information was provided.Date of birth: (b)(6).Sex/gender: male if implanted, give date: (b)(6) 2016.If explanted, give date: (b)(6) 2017.Device available for evaluation? yes.Returned to manufacturer on: 09/08/2017.Device evaluated by manufacturer? no.Reason for non-evaluation: device evaluation anticipated but not yet begun.(b)(4).All pertinent information available to abbott medical optics has been submitted.
Additional Manufacturer Narrative
Additional information was received and it was learnt that the intraocular lens (iol) was returned at the manufacturing site on 09/07/2017 and not on 09/08/2017 as reported in the previous supplemental mdr.Device evaluation: the intraocular lens (iol) was returned at the manufacturing site cut in pieces, most probably to make the explant possible.Considering the condition of the lens additional analysis was not possible.The customer's reported complaint could not be verified.Manufacturing records review: the manufacturing records for the intraocular lens were reviewed.The product was manufactured and released according to specification.A search revealed that no similar complaints for this order number have been received.Labeling review: the directions for use (dfu) were reviewed.The directions for use (dfu) adequately provides instructions and precautions along with warnings for the proper use and handling of the device.As a result of the investigation there is no indication of a product quality deficiency and the reported issue could not be verified.All pertinent information available to abbott medical optics has been submitted.

• Brand Name: TECNIS SYMFONY TORIC
• Common Device Name: MULTIFOCAL IOLS
• Manufacturer (Section D): ABBOTT MEDICAL OPTICS; santa ana CA
• MDR Report Key: 6847545
• Report Number: 9614546-2017-00843
• Device Sequence Number: 60189
• Product Code: POE
• UDI-Device Identifier: 05050474605138
• UDI-Public: (01)05050474605138(17)210806
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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: 2017
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/30/2017

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: 08/06/2021
• Device Model Number: ZXT150
• Device Catalogue Number: ZXT150U165
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/07/2017
• Initial Date Received by Manufacturer: 08/15/2017
• Supplement Date Received by Manufacturer: 09/07/2017; 10/06/2017
• Initial Report FDA Received Date: 09/07/2017
• Supplement Report FDA Received Date: 10/02/2017; 10/31/2017
• 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: 72 YR