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

Model Number	ZXT300
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	No Code Available (3191)
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
It was reported that a physician implanted a symfony toric lens into the patient's eye using help from the ocular response analyzer (ora).Pre-operative intraocular lens (iol) calculations estimated a 13.5 diopter lens and between 300 and 375.The ora estimated a 15.0 diopter with 300, confirmed alignment at 90.There were several measurements taken with the same result.The physician stated he hadn¿t seen this before.The patient had no previous refractive surgery.The physician ended up implanting a 15.0 diopter zxt300 lens on (b)(6) 2017.However, the patient ended up -2.50 with no astigmatism post-operatively.The lens was explanted on (b)(6) 2017.The replacement lens was the same model, but different diopter (13.5).No additional information was provided.
Additional Manufacturer Narrative
Additional information received reported that the patient is a (b)(6) year old male.Also, there was no incision enlargement, vitrectomy, or sutures used.Reportedly, the patient is doing good after the surgery.No additional information provided.Age/date of birth: (b)(6) years old.Gender/sex: male.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 92705
• MDR Report Key: 6860632
• Report Number: 9614546-2017-00868
• Device Sequence Number: 16396702
• Product Code: MFK
• UDI-Device Identifier: 05050474606289
• UDI-Public: (01)05050474606289(17)220505
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/15/2017

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: 05/05/2022
• Device Model Number: ZXT300
• Device Catalogue Number: ZXT300U150
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/19/2017
• Supplement Date Received by Manufacturer: 09/20/2017
• Initial Report FDA Received Date: 09/12/2017
• Supplement Report FDA Received Date: 10/15/2017
• 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: 40 YR