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 zxt300 14.5 diopter intraocular lens was implanted in the left eye (os) on (b)(6) 2017 based on ocular response analyzer (ora) calculations.However, the patient outcome was 1.5 diopter myopia post-operatively.The doctor explanted the lens on (b)(6) 2017.The lens was replaced with the same model number, but lower diopter of 13.0, which was the doctor''s original calculations without ora.The patient is now happy and sees better with a visual acuity of 20/25.It was also noted the patient is 20/25 with a zxt300 in the right eye (od).No additional information was provided.
Additional Manufacturer Narrative
Device evaluation: the product testing was not performed as the complaint device was not returned for evaluation.The reported complaint cannot be verified.Manufacturing record review: manufacturing records were reviewed and the device was manufactured according to specification.A search on complaints history 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 johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Correction: through follow up with the physician it was learned that the implant date ((b)(6 2017) provided in the initial emdr was incorrect.The physician provided the correct implant date as (b)(6) 2017.In addition, the physician provided information that an incision enlargement was performed.However, there were no other complications and the patient is doing well.Also the explanted lens was discarded.No additional information was provided.As a result of the corrected/additional information the following fields were updated accordingly: if implanted, give date: (b)(6) 2017.All pertinent information available to johnson & johnson surgical vision, inc.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: 6844173
• Report Number: 9614546-2017-00841
• Device Sequence Number: 1511519
• Product Code: POE
• UDI-Device Identifier: 05050474606272
• UDI-Public: (01)05050474606272(17)211223
• 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: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/07/2018

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: 12/23/2021
• Device Model Number: ZXT300
• Device Catalogue Number: ZXT300U145
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/11/2017
• Supplement Date Received by Manufacturer: 02/27/2018; 04/10/2018
• Initial Report FDA Received Date: 09/05/2017
• Supplement Report FDA Received Date: 03/29/2018; 05/08/2018
• 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