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)
Date of Event	07/18/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
However an explant/exchange of the lens is planned but not confirmed.(b)(4).Attempts have been made to obtain missing information; however, to date, no response has been received.All pertinent information available to abbott medical optics has been submitted.
Event or Problem Description
It was reported that a zxt150 26.50 diopter intraocular lens (iol) was implanted into the left eye on (b)(6) 2017.Post-operatively, the patient is experiencing poor vision.An exchange of the iol is planned.No additional information was provided.
Additional Manufacturer Narrative
Additional information received reported the patient was female and that she neglected to use pre-operative eye drops as instructed.Patient symptoms were noted to start one week post op, (b)(6) 2017.The lens was explanted on (b)(6) 2017.There was no incision enlargement, vitrectomy, and one suture was used.No post-operative patient injury was reported.No additional information was provided.Age/date of birth: (b)(6).Initially reported age as (b)(6) years; however, based on the date of birth provided; age would have been (b)(6) years.Gender/sex: female.Date of event: (b)(6) 2017.If explanted, give date: (b)(6) 2017.(b)(4).All pertinent information available to abbott medical optics has been submitted.
Additional Manufacturer Narrative
Device evaluation: the product was not returned to 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 product was reviewed.The product was manufactured and released according to specification.A search on complaints revealed that no similar complaints have been received for this production order number.Labeling review: the directions for use (dfu) was reviewed.The 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 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: 6839967
• Report Number: 9614546-2017-00827
• Device Sequence Number: 1601004
• Product Code: POE
• UDI-Device Identifier: 05050474605336
• UDI-Public: (01)05050474605336(17)220430
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 01/24/2018

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: 04/30/2022
• Device Model Number: ZXT150
• Device Catalogue Number: ZXT150U265
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/08/2017
• Supplement Date Received by Manufacturer: 08/30/2017; 01/01/2018
• Initial Report FDA Received Date: 09/01/2017
• Supplement Report FDA Received Date: 09/23/2017; 01/24/2018
• 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: Other
• Patient Age: 55 YR