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

Model Number	ZXT150
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Visual Impairment (2138); Visual Disturbances (2140); No Code Available (3191)
Date of Event	02/14/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).All pertinent information available to abbott medical optics has been submitted.
Event or Problem Description
A patient contacted abbott medical optics to report his experience following implant of a symfony intraocular lens, (iol) model zct150.Patient reports his results are not nearly what was expected.He reports his vision never improved, it deteriorated even after the symfony lens was implanted.He said that he has starbursts at night, close and distance vision are bad, cannot read, and it's impossible to drive especially at night.Patient is thinking that maybe he was implanted with an incorrect lens.Patient suggested we contact his doctor for further information.Follow up was provided by the doctor who confirmed the patient's symptoms.The doctor also confirmed that the lens is well centered, but on wavescan there was significant aberration on the lens.There is a plan to exchange the iol but no definite date has been set.The patient was 20/30 pre-op and has now a best corrected visual acuity (bcva) of 20/50 after 3 weeks.Surgeon performed i-trace and noted a lot of aberrations on the lens.On (b)(6) 2017, further information provided and it was reported that the intraocular lens was explanted today.There was no patient injury and the patient was reported as 20/20 post op.No further information was provided.
Additional Manufacturer Narrative
(b)(4).Additionally, of the initial report was populated with the physician's information, when in fact the patient was the initial reporter for this event.The following fields were updated: additional information was received and it was confirmed that this event involved the patient's left eye and that the explant date was (b)(6) 2017.Also noted is the lens implantation resulted in poor image quality from the outset.Best corrected visual acuity (bcva) at 3 weeks of a poor 20/40 but indistinct 20/50 & 20/50.It¿s impossible for the patient to drive at night due to the poor vision, streaks and light.Initially, it was reported that the surgery outcome interferes with patient's daily activities, however after the lens was exchange, the patient has recovered.Furthermore, voluntary medwatch form was received from fda and it revealed that the following medications were prescribed to the patient: lisinopril, hydrochlorothiazide, sertraline added report source other: medwatch (mw5067689).All pertinent information available to the manufacturer has been submitted.
Additional Manufacturer Narrative
In the initial mdr, reported in describe event or problem model zct150 was indicated.The correct model is actually zxt150.The following has been corrected.Describe event or problem: a patient contacted abbott medical optics to report his experience following implant of a symfony intraocular lens, (iol) model zxt150.All pertinent information available to abbott medical optics has been submitted.
Additional Manufacturer Narrative
Device available for evaluation ¿ yes, returned to manufacturer on 3/21/2017.Device returned to manufacturer ¿ yes.Device evaluation: the device was returned to the manufacturer.Device inspection was performed using a 12x magnification and it was observed that the product was used and dirt particles were present on the optic surface.The reported complaint could not be confirmed in the returned 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: 6347768
• Report Number: 9614546-2017-00123
• Device Sequence Number: 1042352
• Product Code: POE
• UDI-Device Identifier: 05050474605138
• UDI-Public: (01)05050474605138(17)211103
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: consumer,health professional
• Initial Reporter Occupation: Patient
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 06/06/2017

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?: Yes
• Operator of Device: Physician
• Device Expiration Date: 11/03/2021
• Device Model Number: ZXT150
• Device Catalogue Number: ZXT150U165
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/21/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/27/2017
• Supplement Date Received by Manufacturer: Not provided; Not provided; Not provided
• Initial Report FDA Received Date: 02/21/2017
• Supplement Report FDA Received Date: 03/23/2017; 03/28/2017; 06/06/2017
• 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
• Patient Age: 73 YR