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

Model Number	ZXT150
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Codes	Blurred Vision (2137); No Code Available (3191)
Date of Event	09/28/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The lens remains implanted.(b)(4).All pertinent information available to abbott medical optics has been submitted.
Event or Problem Description
It was reported that a zxt150 24.5 diopter intraocular lens (iol) was implanted in the left eye (os) on (b)(6) 2017.The lens was implanted at 85 degrees at pod#1 (post-op day 1) the lens was at 67 degrees.The patient also complained of blurry vision, which interferes with daily activities.No additional information was provided.The lens was repositioned with and a non-amo capsular tension ring was placed on (b)(6) 2017.No additional information provided.
Additional Manufacturer Narrative
Additional information received reported that the lens was rotated from 67 degrees to 88 degrees on the lens reposition surgery date of (b)(6) 2017.Also, post-operatively one day after this reposition, the lens stayed at 88 degrees, the uncorrected visual acuity (ucva) was 20/20-2, and the patient was happy with their new visual acuity.Reportedly, prior to the rotation, the ucva was 20/40+2.No additional information was provided.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 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 92705
• MDR Report Key: 6960602
• Report Number: 9614546-2017-00997
• Device Sequence Number: 11068221
• Product Code: POE
• UDI-Device Identifier: 05050474605299
• UDI-Public: (01)05050474605299(17)211209
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/14/2017

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?: No
• Operator of Device: Physician
• Device Expiration Date: 12/09/2021
• Device Model Number: ZXT150
• Device Catalogue Number: ZXT150U245
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/25/2017
• Supplement Date Received by Manufacturer: 10/18/2017
• Initial Report FDA Received Date: 10/18/2017
• Supplement Report FDA Received Date: 11/14/2017
• 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: 62 YR