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	Blurred Vision (2137); Halo (2227); No Code Available (3191)
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 patient reported seeing a glow around all lights and fears driving after implantation of a zxt150 19.5 diopter intraocular lens (iol) in the right eye.The patient stated that his physician advised him that they can replace the lens but does not guarantee it would resolve the issue.Furthermore, his physician believes that he may only need reading glasses.No further information was provided.
Additional Manufacturer Narrative
Additional information was received and it was learned that the lens was not explanted.The doctor ended up doing a yag (yttrium aluminium garnet) laser treatment, but patient is still having troubles with close up vision and see's the glow/haze around the lights.The left eye is a little clearer and the right eye did not improve.Patient was given tear drops after his initial implant and found out he is allergic to the drops.He was then given a steroid as treatment.Patient indicated that he is experiencing this issue with both of eyes.Additionally, patient also mentioned that his right eye has an astigmatism and is slightly worse than the left eye.At this time, there are no plans to remove the lenses.This report will capture the lens implanted in the right eye.A separate report will capture the lens implanted in the patient's left eye.(b)(4).Device evaluation: the device was not returned to the manufacturer for evaluation.Device inspection could not be performed, therefore the reported issue 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 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: 6679673
• Report Number: 9614546-2017-00580
• Device Sequence Number: 16198260
• Product Code: POE
• UDI-Device Identifier: 05050474605190
• UDI-Public: (01)05050474605190(17)211127
• 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: 2016
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/01/2017

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: 11/27/2021
• Device Model Number: ZXT150
• Device Catalogue Number: ZXT150U195
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/06/2017
• Supplement Date Received by Manufacturer: 07/07/2017
• Initial Report FDA Received Date: 06/29/2017
• Supplement Report FDA Received Date: 08/01/2017
• 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