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 Code	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 during 2017.(b)(4).All pertinent information available to abbott medical optics has been submitted.
Event or Problem Description
It was reported that a zxt225 22.5 diopter intraocular lens (iol) was explanted because of residual myopia.Reportedly, the doctor uses ocular response analyzer (ora) and sometimes the patient does not like what the ora predicted.No additional information was provided.
Additional Manufacturer Narrative
Additional information: additional information received indicated that the replacement lens was model zxt225 (21.5 diopter).There were no complications such as an incision enlargement, vitrectomy, or capsule tear and that the patient outcome is good.The following information was also provided and the sections updated accordingly: age/date of birth: (b)(6).Sex/gender: female.If implanted, give date: (b)(6) 2017.If explanted, give date: (b)(6) 2017.Initial reporter name: (b)(6).Health professional: yes.Occupation: physician.Device available for evaluation? yes.Returned to manufacturer on: 11/13/2017.Device returned to manufacturer? yes.Device evaluation: the device was returned to the manufacturer.Visual inspection with the unaided eye shows the product is cut in half, most probably to make explant possible.Considering the condition of the lens additional analysis is not possible.The reported complaint cannot be confirmed.Manufacturing record review: manufacturing records were reviewed and the device was manufactured according to specification.A search on complaints revealed no similar complaints were received for this production order number to date.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 the manufacturer 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: 7049473
• Report Number: 9614546-2017-01144
• Device Sequence Number: 900802
• Product Code: POE
• UDI-Device Identifier: 05050474605848
• UDI-Public: (01)05050474605848(17)210826
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 01/08/2018

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: 08/26/2021
• Device Model Number: ZXT225
• Device Catalogue Number: ZXT225U225
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2017
• Initial Date Received by Manufacturer: 10/25/2017
• Supplement Date Received by Manufacturer: 12/11/2017
• Initial Report FDA Received Date: 11/21/2017
• Supplement Report FDA Received Date: 01/08/2018
• 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