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

Model Number	ZXR00
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	01/24/2017
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 zxr00 16.5 diopter intraocular lens (iol) was explanted due to a near vision miss.The lens was replaced with the same model lens of a higher diopter (18.0).No further information was provided.
Additional Manufacturer Narrative
Device evaluation the device was returned to the manufacturer for evaluation.Visual inspection of the return sample shows the product was cut in pieces, most probably to make explant possible.The complaint cannot be confirmed.Manufacturing records were reviewed and the lens was manufactured according to specification.A search on complaints revealed no similar complaints for this production order number has been received.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 SYMFONY
• Common Device Name: MULTIFOCAL IOLS
• Manufacturer (Section D): ABBOTT MEDICAL OPTICS; santa ana CA
• MDR Report Key: 6342626
• Report Number: 9614546-2017-00113
• Device Sequence Number: 30379
• Product Code: POE
• UDI-Device Identifier: 05050474579026
• UDI-Public: (01)05050474579026(17)210816
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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
• Report Date (Section B): 05/10/2017

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: 08/16/2021
• Device Model Number: ZXR00
• Device Catalogue Number: ZXR00U0165
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/24/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/19/2017
• Supplement Report FDA Received Date: 05/11/2017
• 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