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

Model Number	ZXT150
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Visual Disturbances (2140); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If explanted, give date: failed explant attempt on (b)(6) 2017; the lens remains implanted.(b)(4).Device evaluation the device was not returned to the manufacturer for evaluation.Device inspection could not be performed, therefore the reported complaint could not be verified.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 intraocular lenses.Based on the investigation results there is no indication of a product quality deficiency.All pertinent information available to the manufacturer has been submitted.
Event or Problem Description
A patient had reported having concerns with glare after implant of a symfony intraocular lens (iol) in her left eye.She also stated that she is considering getting her second eye done.Through follow up, it was learned that the physician will likely perform a lens exchange.The patient is 20/20 for near and far in the first eye but patient says she cannot drive at night due to visual symptoms.After waiting 3 months without much improvement, patient requested iol exchange for a standard toric iol.Unfortunately, the iol exchange attempt was unsuccessful.The physician attempted to free the iol using various techniques, but the anterior and posterior capsule leaflets were fused peripherally, and would not separate with multiple attempts from different angles of approach.The surgeon felt the symfony toric lens could not be explanted safely without causing significant damage to surrounding ocular tissues and zonules, so decided to leave the iol in position.No incision enlargement was needed and a 10-0 nylon suture was used to close the corneal incision as part of her normal technique.The strategy now according to the doctor will be to operate on the right eye, which also has a cataract and astigmatism, with a standard monofocal toric lens, and hopefully that eye will dominate and reduce patients difficulty.No further information was provided.
Additional Manufacturer Narrative
(b)(4).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: 6461048
• Report Number: 9614546-2017-00274
• Device Sequence Number: 580129
• Product Code: POE
• UDI-Device Identifier: 05050474605169
• UDI-Public: (01)05050474605169(17)211010
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/06/2017

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: 10/10/2021
• Device Model Number: ZXT150
• Device Catalogue Number: ZXT150U180
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/09/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/05/2017
• Supplement Report FDA Received Date: 04/06/2017
• 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