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

Model Number	ZXT375
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: unknown, not provided, but the best estimate date is between (b)(6) 2017.(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.
Event or Problem Description
It was reported that a zxt375 14.0 diopter intraocular lens (iol) was implanted in the left eye (os) on (b)(6) 2017.It was later explanted on (b)(6) 2017 due to subluxation of the iol with anisometropia.Also, the doctor stated the anisometropia interfered with the patient's regular activities and the vision was 20/70 post-operatively.There was an incision enlargement, but no vitrectomy or sutures used.The lens was replaced with a non-amo lens.Reportedly, there was no post-operative patient injury.No additional information was provided.

• Brand Name: TECNIS SYMFONY TORIC
• Common Device Name: MULTIFOCAL IOLS
• Manufacturer (Section D): ABBOTT MEDICAL OPTICS; santa ana CA 92705
• MDR Report Key: 6953494
• Report Number: 9614546-2017-00984
• Device Sequence Number: 682422
• Product Code: POE
• UDI-Device Identifier: 05050474606852
• UDI-Public: (01)05050474606852(17)220522
• 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
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/16/2017

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: 05/22/2022
• Device Model Number: ZXT375
• Device Catalogue Number: ZXT375U140
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/21/2017
• Initial Report FDA Received Date: 10/16/2017
• 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