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

Model Number	ZLB00
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Nausea (1970); No Code Available (3191)
Date of Event	03/04/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Device evaluation: the device was not returned to the manufacturer for evaluation as it was discarded.Visual 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.The complaint history search revealed no other complaints for this production order number has been received.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 abbott medical optics has been submitted.
Event or Problem Description
It was initially reported by the physician that a female patient was reported that her "eyes swimming'' and had also experienced nausea after implantation of zlb00 multifocal intraocular lenses (iol).Patient is seeing 20/20 at all distances.The physician indicated that he does not think it is related to the iols.The patient describe the symptom as "a book that can be flipped and it makes a movie".It seemed like she was seeing frame by frame like a movie.The physician tried many things including prescribing pilocarpine to address the patient's symptoms, but they were unsuccessful.The physician noted that patient was orthophoric in primary gaze without diplopia.The symptoms only occurs when she looked from side to side.The symptoms resolved after the physician explanted the lens from both eyes and replaced them with monofocal lenses.Patient is still 20/20 at distance.There was no vitrectomy or incision enlargement required.There was no patient injury.The lens is not available for return as it was thrown away after the lens was explanted.This report will capture the lens explanted from the right eye and a separate mdr will be filed for explant from the left eye.

• Brand Name: TECNIS 1 MULTIFOCAL
• Common Device Name: MULTIFOCAL IOLS
• Manufacturer (Section D): ABBOTT MEDICAL OPTICS; santa ana CA
• MDR Report Key: 6260686
• Report Number: 9614546-2017-00038
• Device Sequence Number: 967095
• Product Code: MFK
• UDI-Device Identifier: 05050474560710
• UDI-Public: (01)05050474560710(17)191005
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/18/2017

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: 10/05/2019
• Device Model Number: ZLB00
• Device Catalogue Number: ZLB00U0220
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/31/2016
• Initial Report FDA Received Date: 01/18/2017
• 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: 68 YR