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

Model Number	ZXR00
Medical Device Problem Codes	Inadequacy of Device Shape and/or Size (1583); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	09/24/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).An attempt has 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 a zxr00 14.5 diopter intraocular lens (iol) was explanted from the patient's operative eye.No additional information was provided.
Additional Manufacturer Narrative
Device available for evaluation?: yes, returned to manufacturer on 10/23/2017.Device evaluation: the product was returned to the manufacturing site for evaluation.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 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 were received for this production order number.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.
Additional Manufacturer Narrative
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.Additional information: additional information received reported the reason for explant was because the aim and refraction was not achieved.Reportedly, the lens did not malfunction.Also, there was no incision enlargement, no vitrectomy, and no capsule tear.The replacement lens was the same model, but different diopter of 13.0 the patient is doing well post-operatively and is a male with date of birth (b)(6) 1962.The operative eye was the left eye and the doctor's name was dr.(b)(6).In addition, the implant date was (b)(6) 2017 and the explant date was (b)(6) 2017.No additional information was provided.All pertinent information available to abbott medical optics has been submitted.

• Brand Name: TECNIS SYMFONY
• Common Device Name: MULTIFOCAL IOLS
• Manufacturer (Section D): ABBOTT MEDICAL OPTICS; santa ana CA 92705
• MDR Report Key: 6970657
• Report Number: 9614546-2017-01021
• Device Sequence Number: 1068376
• Product Code: POE
• UDI-Device Identifier: 05050474591738
• UDI-Public: (01)05050474591738(17)210818
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/12/2018

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: 08/18/2021
• Device Model Number: ZXR00
• Device Catalogue Number: ZXR00U0145
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2017
• Initial Date Received by Manufacturer: 09/28/2017
• Supplement Date Received by Manufacturer: 11/12/2017; 01/15/2018
• Initial Report FDA Received Date: 10/23/2017
• Supplement Report FDA Received Date: 12/11/2017; 02/12/2018
• 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: 55 YR