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

Model Number	ZXT375
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
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 zxt375 24.5 diopter intraocular lens was explanted from the patient's left eye, due to a myopic miscalculation.The doctor attributes the event to patient issues where a previous rk (refractive keratotomy) and lasik had been performed.They were unable to obtain ocular response analyzer (ora) measurements, and had a myopic miss and blurry vision.There was an incision enlargement.The lens was replaced with the same model, but a different, smaller diopter of 21.5.There was no post op patient injury.No additional information was provided.
Additional Manufacturer Narrative
Device evaluation: the device was not returned to the manufacturer for evaluation.Device inspection could not be performed.Failure not confirmed.Manufacturing records were reviewed and the lens was manufactured according to specification.A search on complaints revealed no similar complaints for this production order number has been received.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 as product met manufacturing release criteria.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: 6863153
• Report Number: 9614546-2017-00872
• Device Sequence Number: 117766
• Product Code: POE
• UDI-Device Identifier: 05050474607064
• UDI-Public: (01)05050474607064(17)210816
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/07/2018

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: 08/16/2021
• Device Model Number: ZXT375
• Device Catalogue Number: ZXT375U245
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/21/2017
• Supplement Date Received by Manufacturer: 02/09/2018
• Initial Report FDA Received Date: 09/13/2017
• Supplement Report FDA Received Date: 03/07/2018
• 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