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

Model Number	ZMB00
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Codes	Inflammation (1932); Swelling (2091); Blurred Vision (2137)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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
A patient contacted amo to report that he experienced swelling and that the lens does not seem to be centered.The patient saw his doctor who informed him he had inflammation following implant of the intraocular lens (iol) in his left eye.The doctor prescribed durezol 4 times per day for a week and had taken the patient off of two other medications.The patient had experienced blurry vision and during a visit with the doctor, was told by the doctor that the lens had moved and was maybe due to inflammation.The doctor chose to take a wait and see approach before determining if a re-centering of the lens was needed.Further information was received from the patient who reports that he is seeing better than ever and no longer has issues with his vision.Everything was feeling better on (b)(6) 2016.No further information was provided.
Additional Manufacturer Narrative
Device evaluation: the device was not returned to the manufacturer for evaluation.To date, the lens remains implanted.Device inspection could not be performed, therefore the reported complaint could not be verified.Manufacturing records were reviewed and the lens was manufactured according to specification.A search on complaints revealed no similar complaints were received for this order number to date.The directions for use (dfu) was reviewed.The dfu adequately provides instructions and precautions for the proper use and handling of the intraocular lenses.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: 6259265
• Report Number: 9614546-2017-00037
• Device Sequence Number: 19074453
• Product Code: MFK
• UDI-Device Identifier: 05050474535541
• UDI-Public: (01)05050474535541(17)180323
• 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: 2016
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date (Section B): 02/23/2017

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: 03/23/2018
• Device Model Number: ZMB00
• Device Catalogue Number: ZMB00U0160
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 12/23/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/18/2017
• Supplement Report FDA Received Date: 02/23/2017
• 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