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
Age/date of birth: unknown, information not provided.Gender/sex: unknown, information not provided.Date of event: unknown, exact date not provided (2017).(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 zxt225 16.5 diopter intraocular lens (iol) was implanted on (b)(6) 2017.Post-operatively, the patient was unhappy with the lens and it was later explanted on (b)(6) 2017.No additional information was provided.
Additional Manufacturer Narrative
Additional information was received and it was learnt that the intraocular lens (model zxt225, +16.5 diopter) was explanted from the right eye of a (b)(6) year-old female patient.No incision enlargement, no vitrectomy was performed, no sutures were used and no patient injury post-op was reported.Another lens different model and higher diopter (zlb00 +17.0) was implanted as a replacement.No further information was provided.Date of birth: (b)(6).Sex/gender: female.All pertinent information available to abbott medical optics has been submitted.
Additional Manufacturer Narrative
The following updated information was known at the time of submission of follow-up #1 however was inadvertently not updated/included: initial reporter name and address: (b)(6).Health professional - yes.Physician.Device available for evaluation?: yes, returned to manufacturer on 09/28/2017.Device evaluation: the product was returned to the manufacturing site for evaluation.Visual inspection with the unaided eye showed 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 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: 6854316
• Report Number: 9614546-2017-00859
• Device Sequence Number: 496343
• Product Code: POE
• UDI-Device Identifier: 05050474605725
• UDI-Public: (01)05050474605725(17)211101
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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,Followup
• Report Date (Section B): 11/08/2017

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: ZXT225U165
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2017
• Initial Date Received by Manufacturer: 08/15/2017
• Supplement Date Received by Manufacturer: 09/07/2017; 10/13/2017
• Initial Report FDA Received Date: 09/11/2017
• Supplement Report FDA Received Date: 10/03/2017; 11/08/2017
• 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