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

Model Number	ZXT150
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Visual Impairment (2138); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: unknown not provided.If explanted, give date: not applicable.Explant was planned for (b)(6) 2017 but has not been confirmed.(b)(4).All pertinent information available to abbott medical optics has been submitted.
Event or Problem Description
It was reported that a symfony toric intraocular lens (model zxt150 +19.0 diopters) was scheduled to be explanted on (b)(6) 2017, from the left eye of a female patient because the patient was unhappy with the result.Reportedly, the patient had no reading vision and poor distance vision.Additional information was received and it was learnt that the surgeon attributes the event to patient issues.The poor distance and near vision occurred with and without residual correction placed.No further information was provided.
Additional Manufacturer Narrative
Device evaluation: the intraocular lens (iol) was not returned at the manufacturing site; therefore product testing could not be performed and the customer's reported complaint could not be verified.Manufacturing records review: the manufacturing records for the intraocular lens were reviewed.The product was manufactured and released according to specification.A search revealed that no similar complaints for this order number have been received.As a result of the investigation there is no indication of a product quality deficiency and the reported issue could not be verified.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
• MDR Report Key: 6746188
• Report Number: 9614546-2017-00672
• Device Sequence Number: 220770
• Product Code: POE
• UDI-Device Identifier: 05050474605183
• UDI-Public: (01)05050474605183(17)210713
• 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
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/10/2017

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: 07/13/2021
• Device Model Number: ZXT150
• Device Catalogue Number: ZXT150U190
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/02/2017
• Supplement Date Received by Manufacturer: 11/12/2017
• Initial Report FDA Received Date: 07/27/2017
• Supplement Report FDA Received Date: 12/11/2017
• 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: Other