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

Model Number	ZXT150
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Explant date: if explanted, give date: lens exchanged is scheduled on (b)(6) 2017, but has not been confirmed.(b)(4).All pertinent information available to the manufacturer has been submitted.
Event or Problem Description
It was reported that a zxt150 10.0 diopter intraocular lens (iol) is planned to be explanted from a female patient's right eye, due to lens rotating.In addition, to the residual cylinder, here spherical power is off by 1.50 diopter.Through follow-up it was learned that the lens was initially implanted on (b)(6) 2017 @axis 112 degrees.No further information was provided.
Additional Manufacturer Narrative
Through follow-up it was confirmed that the lens rotated 62 degress before lens was explanted.There was no incision enlargement, no vitrectomy or sutures required.There was no patient post op injury reported.No further information was provided.All pertinent information available to the manufacturer has been submitted.
Additional Manufacturer Narrative
Corrected data: in follow up #1 it was reported that an explant was conducted however a patient code for explant (3191) was inadvertently not entered.Additionally, outcomes to adverse event should have been updated from other serious to required intervention to prevent permanent impairment/damage.The following sections have been updated accordingly.Outcomes attributed to adverse event: required intervention to prevent permanent impairment/damage.If explanted, give date: explant was performed, but date of explant was not provided.(b)(4).Device evaluation: the intraocular lens (iol) was not returned to the manufacturing site.Therefore, product testing could not be performed and 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 on complaints revealed that no similar complaints have been received for this production order number.Labeling review: the directions for use (dfu) was reviewed.The 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: 6517547
• Report Number: 9614546-2017-00319
• Device Sequence Number: 13817634
• Product Code: POE
• UDI-Device Identifier: 05050474605008
• UDI-Public: (01)05050474605008(17)211007
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/04/2017

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?: Yes
• Operator of Device: Physician
• Device Expiration Date: 10/07/2021
• Device Model Number: ZXT150
• Device Catalogue Number: ZXT150U100
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/28/2017
• Supplement Date Received by Manufacturer: Not provided; 09/11/2017
• Initial Report FDA Received Date: 04/24/2017
• Supplement Report FDA Received Date: 05/25/2017; 10/05/2017
• 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: Other; Required Intervention