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); Visual Impairment (2138); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: exact date unknown, not provided, but the best estimate is end of (b)(6) 2017.Explant date: if explanted, give date: not applicable, as the lens remains implanted.(b)(4).An attempt has 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 zxt375 14.5 diopter intraocular lens (iol) was implanted in the right eye (od) on (b)(6) 2017.Post-operatively, the patient reported his vision was amazing and he loved it, but gradually towards the end of (b)(6) 2017 his vision became blurry.Follow up with the doctor showed that the lens rotated 23 degrees from its original position.Laser treatment - limbal relaxation incision (lri) and lens repositioning was performed about a month from (b)(6) 2017, but with no improvement as the lens was still off by 11 degrees.At the patient's most recent follow up visit with the doctor on (b)(6) 2017, the post-operative refraction without correction was 20/70.However, refraction with correction was 20/25.There is also no plan to explant the lens.Reportedly, the patient has had a long history of astigmatism and had a detached retina in both eyes (ou) a while back.The patient was later referred to a different doctor, who also repositioned the lens with no improvement as the lens did not rotate back.The patient still complained of blurry vision, including the inability to drive and having difficulty reading.No additional information was provided.
Additional Manufacturer Narrative
Device evaluation: the product 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 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: 6967599
• Report Number: 9614546-2017-01004
• Device Sequence Number: 16395135
• Product Code: POE
• UDI-Device Identifier: 05050474606869
• UDI-Public: (01)05050474606869(17)220116
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: consumer,health professional
• Initial Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date (Section B): 11/20/2017

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: 01/16/2022
• Device Model Number: ZXT375
• Device Catalogue Number: ZXT375U145
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/26/2017
• Supplement Date Received by Manufacturer: 10/24/2017
• Initial Report FDA Received Date: 10/21/2017
• Supplement Report FDA Received Date: 11/21/2017
• 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