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

Model Number	ZXT225
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	03/28/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).All pertinent information available to the manufacturer has been submitted.
Event or Problem Description
A report was received that a model zxt225 21.5 diopter intraocular lens (iol) was explanted due to the patient experiencing issues with glare, hyperopia and astigmatism.On (b)(6) 2017 the physician explanted the zxt225 lens and attempted to replace it with a non amo device to help the patient focus a little better.However, this procedure was unsuccessful as the lens did not sit properly, the capsule tore and a vitrectomy was performed.This lens was then replaced with a model zxt300 21.0 diopter lens, but unfortunately it went in the eye upside down and was subsequently also removed from the eye during the same procedure.The physician indicated the lens was not fully placed in the eye.There was no patient injury.Finally a third lens model zxr00 22.0 diopter lens was implanted to leave her balanced with her vision between the two eyes.The patient had corneal edema, but has cleared and has a normal functional retina.She is nearsighted.The patient may do a prk (photorefractive keratectomy) in the future or a lasik procedure.This lens was not saved for return.
Additional Manufacturer Narrative
Device available for evaluation ¿ yes, returned to manufacturer on 05/11/2017.Device evaluation: the device was returned to the manufacturer.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.The customer's reported issue could not be confirmed in the returned lens sample.Manufacturing records were reviewed and the lens was manufactured according to specification.A search on complaints revealed that no similar complaints were received for this production order number.The directions for use (dfu) was reviewed.The dfu adequately provides instructions and precautions for the proper use and handling of the device.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 TORIC
• Common Device Name: MULTIFOCAL IOLS
• Manufacturer (Section D): ABBOTT MEDICAL OPTICS; santa ana CA
• MDR Report Key: 6523770
• Report Number: 9614546-2017-00326
• Device Sequence Number: 385817
• Product Code: POE
• UDI-Device Identifier: 05050474605824
• UDI-Public: (01)05050474605824(17)211012
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/12/2017

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: 10/12/2021
• Device Model Number: ZXT225
• Device Catalogue Number: ZXT225U215
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/11/2017
• Initial Date Received by Manufacturer: 03/28/2017
• Supplement Date Received by Manufacturer: 06/19/2017
• Initial Report FDA Received Date: 04/26/2017
• Supplement Report FDA Received Date: 07/12/2017
• 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: 38 YR