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

Model Number	ZKB00
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Blurred Vision (2137); Visual Disturbances (2140)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The lens remains implanted.Device evaluation: the lens was not returned to the manufacturer for evaluation as the lens remains implanted.The reported complaint could not be verified.Manufacturing records were reviewed and the lens was manufactured according to specification.There were no non-conformances with respect to the manufacturing process.There were no associated nonconformity reports.A search on complaints revealed no other 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.
Event or Problem Description
It was reported that a zkb00 21.5 diopter intraocular lens was implanted on (b)(6) 2016, on the right eye of a male patient.The patient has many issues with the focus point since the surgery.He is unable to read and everything is blurry.Patient is requesting guidance to see if this is normal and how long it will take before the issues disappears.He has seen his physician and he was told that his eye has no issues.Per the patient, his physician has done a wonderful job on the implant, but patient is just unable to see.The patient's last doctors visit was on (b)(6).During that time, the doctor continued to prescribe and treat the patient with durezol.The patient has a follow up visit scheduled.

• Brand Name: TECNIS 1 MULTIFOCAL
• Common Device Name: MULTIFOCAL IOLS
• Manufacturer (Section D): ABBOTT MEDICAL OPTICS; santa ana CA
• MDR Report Key: 6012416
• Report Number: 9614546-2016-00500
• Device Sequence Number: 473757
• Product Code: MFK
• UDI-Device Identifier: 05050474560116
• UDI-Public: (01)05050474560116(17)200418
• Combination Product (Y/N): N
• 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
• Report Date (Section B): 10/07/2016

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: 04/18/2020
• Device Model Number: ZKB00
• Device Catalogue Number: ZKB00U0215
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/12/2016
• Initial Report FDA Received Date: 10/07/2016
• 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