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 Codes	Pain (1994); Blurred Vision (2137); No Code Available (3191)
Date of Event	12/20/2016
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 14.5 diopter intraocular lens (iol) was explanted due to patient not being happy with their vision.The lens was replaced with a zlb00 14.5 diopter lens.No further information was provided.
Additional Manufacturer Narrative
Age/date of birth: (b)(6) 1961.Gender/sex: female.Through followup it was learned that this event involved the left eye of a (b)(6) year old female patient.It was reported that the patient's vision was not as sharp as she would like.Her vision seems smeared.Her vision looks better in the office than when driving.Patient stated that she had pain around the lash line on day one postop.Patient states that the colors are great.(b)(4).All pertinent information available to the manufacturer has been submitted.
Additional Manufacturer Narrative
Device evaluation: the device was not returned to the manufacturer for evaluation.Device inspection could not be performed.Manufacturing records were reviewed and the lens was manufactured according to specification.A search on complaints revealed that no similar complaints were received for this production order number.Based on the investigation results there is no indication of a product quality deficiency.All pertinent information available to the manufacturer has been submitted.
Additional Manufacturer Narrative
Device evaluation: the intraocular lens (iol) was returned to the manufacturer.Visual inspection with the unaided eye showed that the product was cut in half, most probably to make the explant possible.Considering the condition of the lens additional analysis was not possible.The customer's reported complaint cannot be confirmed.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
• MDR Report Key: 6248486
• Report Number: 9614546-2017-00026
• Device Sequence Number: 19050974
• Product Code: POE
• UDI-Device Identifier: 05050474606869
• UDI-Public: (01)05050474606869(17)210629
• Combination Product (Y/N): Y
• 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: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 07/19/2018
• Report Date (Section F): 01/01/2005

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: 06/29/2021
• Device Model Number: ZXT375
• Device Catalogue Number: ZXT375U145
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2018
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 12/19/2016
• Supplement Date Received by Manufacturer: Not provided; Not provided; 06/26/2018
• Initial Report FDA Received Date: 01/13/2017
• Supplement Report FDA Received Date: 04/03/2017; 05/02/2017; 07/19/2018
• 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
• Patient Age: 55 YR
• Date Report Sent to FDA: 01/01/2005