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); Visual Impairment (2138); Halo (2227)
Date of Event	12/29/2016
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 zxt150 21.5 diopter intraocular lens (iol) was explanted from a male patient's left eye due to patient experiencing excessive glare, halos decreased acuity and blurry vision.Furthermore, the physician noted that there was lens dislocation.The lens was replaced with a zma00 20.5 diopter iol.There was no incision enlargement and patient has recovered.Additionally, it was reported that the lens was discarded and not available for evaluation.
Additional Manufacturer Narrative
Device evaluation: the product was discarded by the customer.The reported complaint could not be verified.Manufacturing records review: the manufacturing records for the product were reviewed.The product was manufactured and released according to specifications.A search revealed that no additional complaints for this order number have been received.Labeling review: the directions for use (dfu) were reviewed.The dfu adequately provide instructions and precautions along with warnings for the proper use and handling of the device.Conclusion: as a result of the investigation, there is no indication of a product quality deficiency.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: 6386027
• Report Number: 9614546-2017-00173
• Device Sequence Number: 500765
• Product Code: POE
• UDI-Device Identifier: 05050474605237
• UDI-Public: (01)05050474605237(17)211122
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/07/2017

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: 11/22/2021
• Device Model Number: ZXT150
• Device Catalogue Number: ZXT150U215
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/07/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/07/2017
• Supplement Report FDA Received Date: 04/07/2017
• 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: 67 YR