MAUDE Adverse Event Report: ABBOTT MEDICAL OPTICS TECNIS 1 MULTIFOCAL; MULTIFOCAL IOLS

Model Number	ZMB00
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Visual Impairment (2138); Visual Disturbances (2140); Halo (2227)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Age/date of birth: unknown, not provided.Date of event: unknown, was not provided.If implanted; give date: exact date unknown, reported as (b)(6) 2016, entered (b)(6) 2016 as best estimate.If explanted; give date: na (not applicable) to date, the intraocular lens remains implanted.All pertinent information available to abbott medical optics has been submitted.
Event or Problem Description
The customer reported that they have a patient who is not happy with her surgery.Further information reported the patient underwent surgery on both eyes, (b)(6) 2016, the exact implant dates were not provided.The onset date of the patient's symptoms was not provided.The patient can not see up close, within 6 inches.Refocusing is difficult, such as the focus from the computer screen to the keyboard and back to the computer screen.Glare at nights makes if difficult to judge distance; difficult to drive.Before surgery there were no focus issues and only slight halos due to the cataracts.When the patient stares at letters, the letters move/shake.Vision on the day after surgery was 20/30 and is now 20/50.No further information was provided.The patient had two lenses implanted; therefore, reporting on both lenses.This report represents the second of two lens implants.
Additional Manufacturer Narrative
The device was not returned to the manufacturer for evaluation.Device inspection could not be performed, therefore the reported issue could not be verified.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 1 MULTIFOCAL
• Common Device Name: MULTIFOCAL IOLS
• Manufacturer (Section D): ABBOTT MEDICAL OPTICS; santa ana CA
• MDR Report Key: 6232192
• Report Number: 9614546-2017-00012
• Device Sequence Number: 16370482
• Product Code: MFK
• UDI-Device Identifier: 05050474535657
• UDI-Public: (01)05050474535657(17)190521
• 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
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/08/2017

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: 05/21/2019
• Device Model Number: ZMB00
• Device Catalogue Number: ZMB00U0215
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 12/13/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/09/2017
• Supplement Report FDA Received Date: 06/08/2017
• 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