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

Model Number	ZXT225
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Code Available (3191)
Date of Event	07/20/2017
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 patient underwent an explant of a tecnis symfony toric intraocular lens (iol), model zxt225 18.0 diopter.No additional information provided.
Additional Manufacturer Narrative
Correction: in the supplemental mdr it was reported that the device was returned to the manufacturer on 08/11/2017, which was in error.The correct return date to the manufacturer was 08/14/2017.The following section has been updated accordingly.No additional information was provided.Device available for evaluation?: yes, returned to manufacturer on 08/14/2017.All pertinent information available to abbott medical optics has been submitted.
Additional Manufacturer Narrative
Additional information received reported the lens was inserted and removed from the left eye (os) by dr.Scott perkins during the same surgical date of (b)(6) 2017, due to an unspecified lens damage.There was no incision enlargement or vitrectomy.The patient is doing okay.Also, the lens was replaced with the same model and diopter.In addition, it was reported the patient is female with date of birth (b)(6).No additional information was provided.If implanted, give date: not applicable as this lens was inserted and removed.If explanted, give date: not applicable as this lens was inserted and removed.Device available for evaluation?: yes, returned to manufacturer on 08/11/2017.Initial reporter: dr.(b)(6).Health professional: yes.Occupation: physician.Device returned to manufacturer?: yes.(b)(4).Device evaluation: the intraocular lens (iol) was returned to the manufacturing site for evaluation.Visual inspection at 12x microscope magnification showed the product is damaged on the anterior and posterior side.Part of the optic body was cut, most likely to make explant possible.Considering the condition of the returned lens, no additional analysis is possible.Manufacturing records review: the manufacturing records for the intraocular lens were reviewed.The product was manufactured and released according to specification.A search on complaints revealed that no similar complaints were received for this production order number.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 92705
• MDR Report Key: 6806233
• Report Number: 9614546-2017-00778
• Device Sequence Number: 999107
• Product Code: POE
• UDI-Device Identifier: 05050474605756
• UDI-Public: (01)05050474605756(17)211026
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/21/2017

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: 10/26/2021
• Device Model Number: ZXT225
• Device Catalogue Number: ZXT225U180
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/14/2017
• Initial Date Received by Manufacturer: 07/26/2017
• Supplement Date Received by Manufacturer: 09/12/2017; 10/25/2017
• Initial Report FDA Received Date: 08/19/2017
• Supplement Report FDA Received Date: 10/09/2017; 11/21/2017
• 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: 64 YR