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 Codes	Blurred Vision (2137); Halo (2227); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The lens remains implanted.(b)(4).All pertinent information available to the manufacturer has been submitted.
Event or Problem Description
A patient's husband initially reported that his wife received a symfony lens implant in each eye and has experienced halos and glare and has completely lost her vision over time.Through follow up additional information was provided.The patient¿s first eye was implanted around (b)(6) and the second eye was done around (b)(6) timeframe.For the first 2 weeks, her vision was perfect near and far, however, after 2 weeks her vision drastically deteriorated and became very blurry.She could not drive at night or read and she does not want to wear glasses.She will drive during the day only to familiar places.Her left eye is better than her right.The patient saw her two and half weeks ago, and the doctor said her vision improved somewhat and that her eye is healing.The doctor gave her glasses to help her with her near vision, however, it hurts her eyes and strains them and are uncomfortable.The patient sought a second and third opinion to see what her options are and was given conflicting information.One doctor said she could switch to a monofocal lens and another doctor stated not to take the lens out and to give it more time to heal.For now, she will wait for her eye to heal even more.This report will capture the lens implanted in the left eye and a separate report will be filed for the right eye.No further information was provided.
Additional Manufacturer Narrative
Device evaluation: the intraocular lens (iol) was not returned to the manufacturing site as it remains implanted.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: 6769929
• Report Number: 9614546-2017-00708
• Device Sequence Number: 13673292
• Product Code: POE
• UDI-Device Identifier: 05050474605848
• UDI-Public: (01)05050474605848(17)211102
• Combination Product (Y/N): N
• 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: consumer,other,user facility
• Initial Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial,Followup
• Report Date (Section B): 10/06/2017

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: 11/02/2021
• Device Model Number: ZXT225
• Device Catalogue Number: ZXT225U225
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/12/2017
• Supplement Date Received by Manufacturer: 09/11/2017
• Initial Report FDA Received Date: 08/06/2017
• Supplement Report FDA Received Date: 10/07/2017
• 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