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)
Date of Event	12/19/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The lens remains implanted.(b)(4).All pertinent information available to the manufacturer has been submitted.
Event or Problem Description
It was reported that the patient experienced an unexpected (post op) outcome after implant of a zxt225 16.5 diopter intraocular lens.Through follow up it was learned that the implant affected the patient's daily activities and they were very unhappy with the outcome.It was also learned that the physician will proceed with a yttrium-aluminum-garnet (yag) capsulotomy first; then expect the need to perform a photorefractive keratectomy (prk).The doctor will evaluate the situation again to determine the possibility of needing to remove the implanted lens.No further information was provided.
Additional Manufacturer Narrative
Additional information received reported that a photorefractive keratectomy (prk) was performed to correct for the inaccurate iol.The patient/surgeon thought this was a better option versus an explant of the lens.No additional information was provided.Device evaluation: the intraocular lens (iol) was not returned to the manufacturing site as it remains implanted.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 intraocular lens were 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
• MDR Report Key: 6495181
• Report Number: 9614546-2017-00301
• Device Sequence Number: 16508474
• Product Code: POE
• UDI-Device Identifier: 05050474605725
• UDI-Public: (01)05050474605725(17)211103
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/25/2017

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: 11/03/2021
• Device Model Number: ZXT225
• Device Catalogue Number: ZXT225U165
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/20/2017
• Supplement Date Received by Manufacturer: 07/26/2017
• Initial Report FDA Received Date: 04/14/2017
• Supplement Report FDA Received Date: 08/25/2017
• 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
• Patient Age: 75 YR