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

Model Number	ZXT300
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Blurred Vision (2137); Visual Impairment (2138); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: unknown, not provided, but the best estimate date is between (b)(6) 2017.(b)(4).All pertinent information available to abbott medical optics has been submitted.
Event or Problem Description
It was reported that a zxt300 16.0 diopter intraocular lens (iol) was implanted into the patient's left eye (os) on (b)(6) 2017.It was later explanted on (b)(6) 2017, because the patient experienced blurry vision and had difficulty seeing street signs.There was no incision enlargement, vitrectomy, or sutures used.The lens was replaced with a zxt150 16.0 diopter iol.Reportedly, there was no patient injury post-operatively and the patient is doing fine.No additional information was provided.
Additional Manufacturer Narrative
Device available for evaluation? yes.Returned to manufacturer on: 12/05/2017.Device returned to manufacturer? yes.Device evaluation: the sample was returned to the manufacturer.Visual inspection was performed with 12x magnification.It can be seen that the product is damaged, scratches can be seen on the posterior side of the optic body.The damage is not related to manufacturing.The reported complaint was not confirmed.Manufacturing record review: manufacturing record review of the production order and related document revealed that the product was manufactured and released according to specification.There was no discrepancy found during the review.A search revealed that no similar complaints were received from this production order.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.

• Brand Name: TECNIS SYMFONY TORIC
• Common Device Name: MULTIFOCAL IOLS
• Manufacturer (Section D): ABBOTT MEDICAL OPTICS; santa ana CA 92705
• MDR Report Key: 7085536
• Report Number: 9614546-2017-01200
• Device Sequence Number: 13678267
• Product Code: POE
• UDI-Device Identifier: 05050474606302
• UDI-Public: (01)05050474606302(17)220601
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/19/2018

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: 06/01/2022
• Device Model Number: ZXT300
• Device Catalogue Number: ZXT300U160
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2017
• Initial Date Received by Manufacturer: 11/07/2017
• Supplement Date Received by Manufacturer: 02/20/2018
• Initial Report FDA Received Date: 12/05/2017
• Supplement Report FDA Received Date: 03/19/2018
• 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