MAUDE Adverse Event Report: ABBOTT MEDICAL OPTICS TECNIS SYMFONY TORIC; MULTIFOCAL IOLS

Model Number	ZXT375
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Codes	Blurred Vision (2137); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).All pertinent information available to the manufacturer has been submitted.
Event or Problem Description
It was reported that a zxt375 17.0 diopter intraocular lens was explanted from a male patient's right eye due to unexpected residual refraction and blurry vision.Additionally, it was learned that the lens rotated twice and did not stay in place.The lens original axis was 104 degrees.At week 1 postop the lens rotated 15 degrees and rotated 45 degrees by postop week 2.The rotation never resulted in a satisfactory refraction or visual acuity and additional calculations showed that even if the lens was rotated into an ideal position, it would not have adequately corrected the astigmatism.Furthermore, at one week post-op the patient had a residual refraction of -2.50 +3.50 x 90.Patient had uncorrected visual acuity (va) of 20/150 at distance and 20/100 at near.Patient refracts to 20/20+.Through follow-up it was learned that the lens was replaced with a non-amo lens.No patient injury was reported.
Additional Manufacturer Narrative
Device available for evaluation ¿ yes, returned to manufacturer on 5/12/2017.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 customer's reported issue could not be confirmed in the returned lens sample.Manufacturing records were reviewed and the lens was manufactured according to specification.A search on complaints revealed that no similar complaints were received for this production order number.The directions for use (dfu) was reviewed.The dfu adequately provides instructions and precautions for the proper use and handling of the device.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
• MDR Report Key: 6562362
• Report Number: 9614546-2017-00405
• Device Sequence Number: 1170485
• Product Code: POE
• UDI-Device Identifier: 05050474606913
• UDI-Public: (01)05050474606913(17)211115
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Report Date (Section B): 07/14/2017

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?: Yes
• Operator of Device: Physician
• Device Expiration Date: 11/15/2021
• Device Model Number: ZXT375
• Device Catalogue Number: ZXT375U170
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2017
• Initial Date Received by Manufacturer: 04/13/2017
• Supplement Date Received by Manufacturer: 06/21/2017
• Initial Report FDA Received Date: 05/11/2017
• Supplement Report FDA Received Date: 07/14/2017
• 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
• Patient Age: 44 YR