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

Model Number	ZXT300
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Codes	Blurred Vision (2137); Visual Disturbances (2140); Halo (2227)
Date of Event	02/24/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If explanted, give date: not applicable as the lens remains in patient's eye.(b)(4).All pertinent information available to the manufacturer has been submitted.
Event or Problem Description
It was reported that after implantation of a zxt300 intraocular lens, at 1 week post op, the patient was experiencing dysphotopsia, starbursts and flare, especially at dark.An exam on the patient's eye showed that the lens was approximately 17 degrees off axis, instead of 93 it was at 110.As a result the physician is planning on repositioning the lens.Through follow-up, additional information was received.It was learned that lens was implanted in a male patient's right eye.Patient was experiencing more glare, starburst, halos and patient is very dissatisfied.The patient is also experiencing distortion and blurred vision.Through additional follow up it was later learned that the patient is doing fine.(b)(6) 2017 - od visual acuity (post op day 1): distance - 20/100 ph: 20/40.(b)(6) 2017 - od visual acuity: distance - 20/40.No further information was provided.
Additional Manufacturer Narrative
Device evaluation: the product testing was not performed as the complaint device was not returned for analysis.The reported complaint cannot be confirmed.Manufacturing record review: manufacturing records were reviewed and the device was manufactured according to specification.A search on complaints revealed no similar complaints were received for this production order number to date.Labeling review: the directions for use (dfu) was reviewed.The dfu adequately provides instructions and precautions for the proper use and handling of the product.Conclusion: 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: 6451862
• Report Number: 9614546-2017-00262
• Device Sequence Number: 16362376
• Product Code: POE
• UDI-Device Identifier: 05050474606180
• UDI-Public: (01)05050474606180(17)210820
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/12/2017

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?: Yes
• Operator of Device: Physician
• Device Expiration Date: 08/20/2021
• Device Model Number: ZXT300
• Device Catalogue Number: ZXT300U100
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/03/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/02/2017
• Supplement Report FDA Received Date: 05/12/2017
• 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: 56 YR