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	Visual Disturbances (2140); Halo (2227); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Age/date of birth: unknown, not provided.Gender/sex: unknown, not provided.Date of event: unknown, information not provided.If implanted, give date: unknown, information not provided.If explanted, give date: not applicable, explant not performed.(b)(4).All pertinent information available to abbott medical optics has been submitted.
Event or Problem Description
It was reported that a patient had a tecnis symfony toric intraocular lens (iol), model zxt225 20.5 diopters, implanted into the operative eye.Patient complains of no extended range of visual acuity from 28 to 34 inches, rings, blurring and clouding of her range of visual acuity, daytime glare, and night time halos.Also, there may be a possible explant.No additional information is provided.
Additional Manufacturer Narrative
Additional information was received and it was learnt that the toric intraocular lens (iol) was explanted in a secondary surgical procedure from the right eye of a female patient because of poor adaptation to the lens in regards of range of vision.The patient distance was approximately -0.75 and she only had a small midrange of clear vision.During the explant there was no incision enlargement, no vitrectomy was performed, no sutures used and no patient post-op injury was reported.The account commented that there was a mild complication during the explant/re-implant surgery which is resolving.Another toric was implanted as a replacement, model and diopter unknown.No further information was provided.Date of birth: (b)(6).Sex/gender: female.Outcomes attributed to adverse event from other to required intervention.If implanted, give date: (b)(6) 2017.If explanted, give date: (b)(6) 2017.Device available for evaluation? yes.Returned to manufacturer on: 09/07/2017.Device returned to manufacturer? yes.Device evaluated by manufacturer? no.Reason for non-evaluation: device evaluation anticipated, but not yet begun.Device evaluation: visual inspection of the returned device with the unaided eye shows the product is cut in pieces, most probably to make explant possible.Considering the condition of the lens additional analysis is not possible.Manufacturing records review: the manufacturing records for the intraocular lens were reviewed.The product was manufactured and released per specification.A search of complaints related to the production order number revealed that no similar complaints for this order number have been received.Labeling review: the directions for use (dfu) were reviewed.The directions for use (dfu) adequately provides instructions and precautions along with warnings for the proper use and handling of the device.As a result of the investigation there is no indication of a product quality deficiency and the reported issue was not confirmed.All pertinent information available to abbott medical optics has been submitted.
Additional Manufacturer Narrative
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: 6804817
• Report Number: 9614546-2017-00764
• Device Sequence Number: 11022709
• Product Code: POE
• UDI-Device Identifier: 05050474605800
• UDI-Public: (01)05050474605800(17)211101
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/12/2017

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: 11/01/2021
• Device Model Number: ZXT225
• Device Catalogue Number: ZXT225U205
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/07/2017
• Initial Date Received by Manufacturer: 07/25/2017
• Supplement Date Received by Manufacturer: 08/25/2017; 09/18/2017
• Initial Report FDA Received Date: 08/18/2017
• Supplement Report FDA Received Date: 09/19/2017; 10/12/2017
• 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; Required Intervention